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QUEST MEDICAL INC

Last updated May 24, 2026

What QUEST MEDICAL INC makes

Quest Medical Inc manufactures intravenous administration tubing extension sets, reusable cardiopulmonary bypass system heat exchangers, and cardioplegia solution administration kits. The company also produces single-use aorta punches, non-bioabsorbable surgical support tape, unidirectional flow and pressure control valves for cardiopulmonary bypass systems, lacrimal intubation sets, and stopcocks.

The company is based in the United States, and its product portfolio includes devices categorized as Class I, Class II, and Class U. These devices are listed in the FDA 510(k) and FDA UDI databases.

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

Frequently asked questions

Where is Quest Medical Inc based?

Quest Medical Inc is based in the United States. This information is provided to clarify the company's geographical origin and operational base as stated in the official device data.

What types of medical devices does Quest Medical Inc manufacture?

The company manufactures a diverse range of medical equipment, including intravenous administration tubing extension sets, reusable cardiopulmonary bypass system heat exchangers, and cardioplegia solution administration kits. Additionally, they produce single-use aorta punches, non-bioabsorbable surgical support tape, unidirectional flow and pressure control valves for cardiopulmonary bypass systems, lacrimal intubation sets, and stopcocks.

How are the devices from Quest Medical Inc classified?

The devices produced by Quest Medical Inc are classified as Class I, Class II, and Class U. These classifications are assigned based on the regulatory framework governing the specific medical devices within the company's portfolio.

Which regulatory registries list the devices produced by Quest Medical Inc?

The devices manufactured by Quest Medical Inc are listed in the FDA 510(k) and FDA UDI databases. These registries are used to track and document the regulatory status and identification of the medical devices produced by the company.

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

Information

Country: US
Address: —
Website: questmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-627-0226
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 041810693

Catalogue (311)

Page 1 of 7

Device	Model / Reference	Registries	Class	Status
Q2 IV Administration Set	ASV10115	FDA UDI	Class II	Active
Multiport IV Administration Set	9525B	FDA UDI	Class II	Active
MPS 3 ND Delivery Set w/AA w/106cm (16C)	5ND3103	FDA UDI	Class II	Active
Precision Delivery IV Extension Set, Amber	PDV60A	FDA UDI	Class II	Active
MPS 3 Mini Prime Delivery Set w/AA	7003101	FDA UDI	Class II	Active
VRV-II Vacuum Relief Valve	4003203	FDA UDI	Class II	Active
7 in (18cm) Y-Extension Set w/ 2 check valves	9250	FDA UDI	Class II	Active
Mps	5001102-AS	FDA UDI	Class II	Active
Q2 10ft/3m IV Extension Set	95726	FDA UDI	Class II	Active
Mps	5051101	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch	RCL50	FDA UDI	Class I	Active
Precision Delivery IV Extension Set	PDMV60	FDA UDI	Class II	Active
Q2 IV Administration Set	ASV101Y	FDA UDI	Class II	Active
MPS 3 Console Adapter	5301025	FDA UDI	Class II	Active
Mps 2	5001032	FDA UDI	Class II	Active
MPS2 Console	5201260	FDA UDI	Class II	Active
CleanCut 5.0 mm Non sterile Bullet Punch	RCB50BNS	FDA UDI	Class I	Active
Retract-o-Tape 18g x 30.5cm Semi-Pointed Needle	1071	FDA UDI	Class I	Active
44 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site	9541	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PD60F	FDA UDI	Class II	Active
Mps	5051107	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PDBM05CV1	FDA UDI	Class II	Active
100 in (254 cm) Q2 MultiPort IV administration set	9525A	FDA UDI	Class II	Active
MPS Back Up System, front crank	5001021	FDA UDI	Class II	Active
Precision Delivery IV Extension Set, Amber	PDTV05FA	FDA UDI	Class II	Active
CleanCut 4.5 mm Nonsterile Aortic Punch	RCC45BNS	FDA UDI	Class I	Active
MPS Water Hose Kit	5303030	FDA UDI	Class II	Active
MPS2 console	5202260	FDA UDI	Class II	Active
High-Flow Extension Set	HF0135	FDA UDI	Class II	Active
LacriCATH	LDC508T	FDA UDI	U	Active
MPS 3 Delivery Set w/AA w/183 Line (10C)	5003102-AS	FDA UDI	Class II	Active
High-Flow 4-Way Stopcock	ST03	FDA UDI	Class II	Active
LacriCATH	DCP213-BIT	FDA UDI	U	Active
Exoflex 14.5in. IVExtension Set	95787	FDA UDI	Class II	Active
Precision Delivery Trifurcated IV Extension Set	PDTV05	FDA UDI	Class II	Active
Retract-o-Tape 16g x 45.8cm Heavy Wall	1032	FDA UDI	Class I	Active
MPS 3 ECG Cable	513UECG	FDA UDI	Class II	Active
MPS Water Circuit Adapter, 16C	5161110	FDA UDI	Class II	Active
CleanCut 4.0 mm Nonsterile Bullet Punch	RCB40BNS	FDA UDI	Class I	Active
16 in. (38 cm) Q2 Checkmate extension set	9548	FDA UDI	Class II	Active
Mps	5001110	FDA UDI	Class II	Active
MPS Back Up System, front crank	5001028	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch, 4.0 mm	RCC40	FDA UDI	Class I	Active
Mps	5001103	FDA UDI	Class II	Active
PerfectCut Rotating Aortic Punch	RCB50	FDA UDI	Class I	Active
MPS 3 UI Power Communication Cable	513PWCC-10	FDA UDI	Class II	Active
MPS Power Cord Keeper	5001029	FDA UDI	Class II	Active
RetroGuard Arterial Safety Valve	4007200	FDA UDI	Class II	Active
Tie-V Securement Device	QIVB0060	FDA UDI	Class I	Active
Mps	5001102	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Authorities

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FDA Recalls (7)

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

Date	Recall No.	Class	Status	Reason
Jul 14, 2023	Z-0197-2024	—	open, classified	For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.
Dec 23, 2022	Z-1100-2023	—	open, classified	Delivery Sets may have tubing that could become detached that could result in patient infection.
Dec 17, 2019	Z-2107-2020	—	terminated	Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.
Oct 28, 2015	Z-0361-2016	—	terminated	The products have been found to intermittently exhibit a seal failure during use.
Feb 26, 2015	Z-1368-2015	—	terminated	Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
Jul 29, 2010	Z-1924-2011	—	terminated	User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
May 23, 2003	Z-1037-03	—	terminated	Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.