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NURSE ASSIST, INC.

Last updated September 17, 2026

What NURSE ASSIST, INC. makes

Nurse Assist, Inc. manufactures single-use and reusable electrical medical device connection cables, indwelling urethral catheterization kits for adults, and vascular catheter flush syringes. The company also produces sterile irrigation solutions, including sterile water for device irrigation and non-antimicrobial saline wound irrigation, as well as urological irrigation sets.

The portfolio includes Class I, Class II, and unclassified devices, with regulatory submissions recorded under FDA 510(k) and FDA UDI registries. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Nurse Assist, Inc. manufacture?

Nurse Assist, Inc. specializes in a range of medical devices, primarily focusing on electrical medical device connection cables (both single-use and reusable), indwelling urethral catheterization kits for adults, and vascular catheter flush syringes. Additionally, the company produces sterile irrigation solutions, such as sterile water for device irrigation and non-antimicrobial saline wound irrigation, as well as urological irrigation sets. These products cater to clinical needs in urology, wound care, and medical connectivity.

Where is Nurse Assist, Inc. based, and how does that affect its regulatory oversight?

Nurse Assist, Inc. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The company’s products are submitted for regulatory review through FDA pathways like the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. Since the FDA regulates medical devices in the U.S., compliance with its guidelines is essential for market authorization.

Which regulatory registries list Nurse Assist, Inc.’s devices, and why are these important?

Nurse Assist, Inc.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures unique identification of devices for tracking, traceability, and regulatory compliance. These registries help ensure transparency, safety monitoring, and proper classification of the company’s products.

How are Nurse Assist, Inc.’s devices classified by the FDA, and what does that classification mean?

Nurse Assist, Inc.’s devices are classified as Class I, Class II, or unclassified (U) under FDA regulations. Class I devices generally pose the lowest risk and may only require general controls, while Class II devices require special controls to ensure safety and effectiveness. Unclassified devices are those not yet assigned a risk category but are evaluated on a case-by-case basis. Classification determines the regulatory pathway and scrutiny required for market authorization.

What kinds of medical specialties or clinical settings would use Nurse Assist, Inc.’s products?

Nurse Assist, Inc.’s products are designed for use in urology (e.g., indwelling catheters and irrigation sets), wound care (e.g., saline irrigation solutions), and medical connectivity (e.g., reusable/single-use cables for electrical devices). These devices are commonly utilized in hospitals, outpatient clinics, surgical centers, and home healthcare settings where sterile procedures, patient monitoring, and urological interventions are performed.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 4409 Haltom Rd, Haltom City, TX, 76117
Website: xx.xx
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-649-6800
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3002695476
DUNS Number: 869434464

Catalogue (145)

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Device	Model / Reference	Registries	Class	Status
Medical Action	4128	FDA UDI	Class I	Unknown
Quantum	QW2201	FDA UDI	Class II	Active
Nurse Assist	57850	FDA UDI	Class II	Active
SteriCare Solutions	6260	FDA UDI	U	Active
Nurse Assist	1210-SF	FDA UDI	Class II	Active
Mobile Instrument	QS2102M	FDA UDI	Class II	Active
Storz	277KBD	FDA UDI	Class II	Active
Mobile Instrument	QI1004M	FDA UDI	Class II	Active
Nurse Assist	1210	FDA UDI	Class II	Active
Nurse Assist	PT00014226	FDA UDI	Class II	Active
SteriCare Solutions	6503	FDA UDI	U	Active
Mobile Instrument	QI1003M	FDA UDI	Class II	Active
Mobile Instrument	QI1002M	FDA UDI	Class II	Active
Wolf	8101.001	FDA UDI	Class II	Active
Nurse Assist	7503	FDA UDI	Class I	Active
Nurse Assist	7201	FDA UDI	Class II	Active
Covidien	8881573121	FDA UDI	Class II	Active
Covidien	8881573121	FDA UDI	Class II	Active
Covidien	8881573125	FDA UDI	Class II	Active
Mckesson	37-202	FDA UDI	Class II	Active
Quantum	QS2103	FDA UDI	Class II	Active
Nurse Assist	7305	FDA UDI	Class I	Active
Quantum	QS2101	FDA UDI	Class II	Active
Nurse Assist	1203-BP	FDA UDI	Class II	Active
Nurse Assist, Inc.	2760	FDA UDI	Class I	Active
Orion	30296	FDA UDI	Class II	Active
Storz	277KAD	FDA UDI	Class II	Active
Nurse Assist	52332	FDA UDI	Class II	Active
Nurse Assist	7204	FDA UDI	Class I	Active
Quantum	QD2103	FDA UDI	Class II	Active
Medical Action	4118	FDA UDI	Class I	Unknown
Quantum	QI2900	FDA UDI	Class II	Active
SteriCare Solutions	6291	FDA UDI	U	Active
Nurse Assist	6492776	FDA UDI	U	Active
Nurse Assist	7302	FDA UDI	Class II	Active
Stryker	250-040-012	FDA UDI	Class II	Active
Quantum	QI2402	FDA UDI	Class II	Active
Nurse Assist	51617	FDA UDI	Class II	Active
Nurse Assist	1030A	FDA UDI	Class II	Active
Medical Action	4120	FDA UDI	Class I	Unknown
Mckesson	37-232	FDA UDI	Class II	Active
Nurse Assist	51638	FDA UDI	Class II	Active
Nurse Assist	7201	FDA UDI	Class II	Active
Nurse Assist	7501	FDA UDI	Class II	Active
Nurse Assist	1205	FDA UDI	Class II	Active
Nurse Assist	7303	FDA UDI	Class I	Active
Nurse Assist	7203	FDA UDI	Class I	Active
Quantum	QI2401	FDA UDI	Class II	Active
Nurse Assist	1010	FDA UDI	Class II	Active
SteriCare Solutions	6220	FDA UDI	U	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (64)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Nurse Assist, Inc. has 64 recall records spanning from January 20, 2011, to November 6, 2023, with statuses recorded as open, classified, or terminated. The recalls involve irrigation products, including sodium chloride and sterile water for irrigation, due to potential lack of sterility assurance, as well as procedure trays containing recalled components from the Triad Group—such as PVP solution packs, alcohol prep pads, and sterile lubricating jelly packs—due to contamination risks or inadequate sterilization. One record cites potential contamination with *B. cepacia*.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 6, 2023	Z-0514-2024	—	open, classified	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Nov 6, 2023	Z-0512-2024	—	open, classified	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Nov 6, 2023	Z-0515-2024	—	open, classified	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Nov 6, 2023	Z-0511-2024	—	open, classified	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Nov 6, 2023	Z-0513-2024	—	open, classified	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Oct 4, 2016	Z-0926-2017	—	terminated	Potential contamination with B. cepacia.
Sep 2, 2011	Z-0501-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0494-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0497-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0493-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0491-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0495-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0504-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0500-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0499-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0492-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0503-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0502-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0498-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0490-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0496-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011	Z-0505-2012	—	terminated	Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Jan 20, 2011	Z-2281-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2285-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2272-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2251-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2257-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2249-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2279-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2290-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2280-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2289-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2284-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2287-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2274-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2258-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2264-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2253-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2273-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2278-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2277-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2256-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2286-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2266-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2288-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2276-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2252-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2261-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2268-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2254-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2267-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2275-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2262-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2250-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2270-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2271-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2263-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2265-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2269-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2259-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2283-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Jan 20, 2011	Z-2255-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2260-2011	—	terminated	The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
Jan 20, 2011	Z-2282-2011	—	terminated	The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.