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NURSE ASSIST, INC.

US

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
—
Phone
800-649-6800
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3002695476
DUNS Number
869434464

Catalogue (145)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Quantum QD1004
FDA UDI
Class IIActive
Nurse Assist 52333
FDA UDI
Class IIActive
Nurse Assist 1210
FDA UDI
Class IIActive
Quantum QI2301
FDA UDI
Class IIActive
Nurse Assist 7301
FDA UDI
Class IIActive
Mobile Instrument QI2407M
FDA UDI
Class IIActive
Nurse Assist 7302
FDA UDI
Class IIActive
Nurse Assist 6024
FDA UDI
Class IIActive
Storz 26176VLD-10
FDA UDI
Class IIActive
Storz 26176
FDA UDI
Class IIActive
Nurse Assist 7301
FDA UDI
Class IIActive
Quantum QI2407
FDA UDI
Class IIActive
SteriCare Solutions 6270
FDA UDI
UActive
Storz 26006MD
FDA UDI
Class IIActive
Quantum QD2201
FDA UDI
Class IIActive
Nurse Assist 1210-BP
FDA UDI
Class IIActive
Wolf 8108.001
FDA UDI
Class IIActive
Storz 277KBD
FDA UDI
Class IIActive
Nurse Assist 7304
FDA UDI
Class IActive
Nurse Assist 1205-BP
FDA UDI
Class IIActive
Nurse Assist 1203
FDA UDI
Class IIActive
Mckesson 37-234
FDA UDI
Class IActive
Nurse Assist 7401
FDA UDI
Class IIActive
SteriCare Solutions 5290
FDA UDI
UActive
Mobile Instrument QI2301M
FDA UDI
Class IIActive
Nurse Assist 7501
FDA UDI
Class IIActive
Quantum QI1003
FDA UDI
Class IIActive
Nurse Assist 1205
FDA UDI
Class IIActive
Nurse Assist 37-202
FDA UDI
Class IIActive
Medical Action 4129
FDA UDI
Class IUnknown
SteriCare Solutions 6250
FDA UDI
UActive
Covidien 6496723
FDA UDI
Class IIActive
Mobile Instrument QS2101M
FDA UDI
Class IIActive
Covidien 8881573123
FDA UDI
Class IIActive
Covidien 8881573123
FDA UDI
Class IIActive
SteriCare Solutions 6210
FDA UDI
UActive
Covidien 6496722
FDA UDI
Class IIActive
SteriCare Solutions 6492775
FDA UDI
UActive
SteriCare Solutions 6290
FDA UDI
UActive
SteriCare Solutions 5280
FDA UDI
UActive
Medi-Choice TRAC1001
FDA UDI
Class IActive
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch K201286
FDA 510(k)
Class IIActive
Wound Flush, Sterile Water & Normal Saline K083042
FDA 510(k)
UActive
Normal Saline Flush K150143
FDA 510(k)
Class IIActive
Lube Jelly Suringe K121390
FDA 510(k)
Class IActive

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.

DateRecall No.ClassStatusReason
Nov 6, 2023Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2016Z-0926-2017—terminated

Potential contamination with B. cepacia.

Sep 2, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-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, 2011Z-2282-2011—terminated

The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.