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A-Med Systems, Inc.

Last updated May 23, 2026

What A-Med Systems, Inc. makes

A-Med Systems, Inc. makes vascular cannulas and centrifugal blood pumps, including models such as the A-MED Vascular Cannula (V24 series), Large Centrifugal Blood Pump (CP-2), Heparin Coated Miniature Centrifugal Bypass Pump System (CP-1H), and A-Miniature Centrifugal Blood Pump System (CPB 2000).

These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. 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 devices does A-Med Systems, Inc. make?

A-Med Systems, Inc. makes vascular cannulas and centrifugal blood pumps, including specific models such as the A-MED Vascular Cannula (V24 series), Large Centrifugal Blood Pump (CP-2), Heparin Coated Miniature Centrifugal Bypass Pump System (CP-1H), and A-Miniature Centrifugal Blood Pump System (CPB 2000).

Where is A-Med Systems, Inc. based?

A-Med Systems, Inc. is based in the United States, as indicated by the country field in the device data.

Which regulatory registry lists the devices made by A-Med Systems, Inc.?

The devices made by A-Med Systems, Inc. are listed in the FDA 510(k) registry, as specified in the LISTED IN field of the device data.

How are the devices made by A-Med Systems, Inc. classified?

The devices made by A-Med Systems, Inc. are classified as Class II medical devices, according to the DEVICE CLASSES field in the provided data.

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

Information

Country: US
Address: —
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LinkedIn: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (434)

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Device	Model / Reference	Registries	Class	Status
Kit, Disposable, Breathing, w/ Foam Nose Clip	Kit, Disposable, Breathing - 180006	FDA UDI	Class II	Active
PFT Kit A, Disposable, 28MM OD Filter	PFT Kit A, 28MM OD Filter - 181128	FDA UDI	Class II	Active
Tubing, 1 1/2" ID, Wire Reinforced	Tubing, 1 1/2" ID, Wire Reinforced - 272200	FDA UDI	Class I	Active
Chart, X-Ref Gould/SRL 42132, 8.5" x 11", Red Grid	Chart, X-Ref Gould/SRL 42132 - 135700	FDA UDI	Class I	Active
Mouthpiece, Disposable Flex, 1-3/8" OD, 2.625" L	Mouthpiece, Flex, 1-3/8" OD, 2.625" L - 162803	FDA UDI	Class I	Active
Adapter, Tube, Plexiglas, 2" TO 1 3/8"	Adapter, Plexiglas, 2" TO 1 3/8" - 114400	FDA UDI	Class I	Active
PFT Kit A	PFT Kit A - 180051	FDA UDI	Class II	Active
Tubing, Smooth Interior, Disposable, 1.375"-36"	Tubing, Smooth Interior, Disposable, 1.375"-36" - 243400	FDA UDI	Class I	Active
Optichamber Diamond w/ Medium, Lite Touch VHC Mask	Optichamber Diamond w/ Medium, Lite Touch VHC Mask - 166403	FDA UDI	Class II	Active
Mouthpiece, Disposable, 3/4" O.D., 2.625" L	Mouthpiece, 3/4" O.D., 2.625" L - 162100	FDA UDI	Class I	Active
Noseclip, Disposable , White, Rubber Pad	Noseclip, Disposable , White, Rubber Pad - 166010	EUDAMEDFDA UDI	Class I	Active
Tubing, Smooth Interior, Hytrel, IMC, 22MM-48"	Tubing, Smooth Interior, Hytrel, IMC, 22MM-48" - 253300	FDA UDI	Class I	Active
Mouthpiece, Disposable, Pediatric, VBMax Adapter	Mouthpiece, Pediatric, Adapter - 163420	FDA UDI	Class I	Active
PFT Kit A, 28MM O.D	PFT Kit A, 28MM O.D - 181129	FDA UDI	Class II	Active
PFT Kit F, VBMax28S	PFT Kit F, VBMax28S - 187169	FDA UDI	Class II	Active
Mouthpiece, Disposable, 1-5/16" O.D., 2.625" L	Mouthpiece, 1-5/16" O.D., 2.625" L - 162700	FDA UDI	Class I	Active
VBMax30, PF Testing Filter	VBMax30 - 156305	FDA UDI	Class II	Active
PFT Kit C, 33 MM O.D.	PFT Kit C, 33 MM O.D. - 183103	FDA UDI	Class II	Active
Syringe, Calibration, 3 Liter, Aluminum, Biomedical Systems	Syringe, Calibration, 3 Liter, Aluminum, Biomedical Systems - 192709	FDA UDI	Class I	Active
Disposable Blue PFT Nose Clip with Foam Pads	Disposable Blue PFT Nose Clip with Foam Pads - 166900	FDA UDI	Class I	Active
Chart Paper, Thermal, for SDI Astra Touch	Chart Paper, Thermal, for SDI Astra Touch - 140750	FDA UDI	Class I	Active
PFT KIT F, VBMax30E with Blue Foam Nose Clip	PFT KIT F, VBMax30E - 189190	FDA UDI	Class II	Active
Mask, Face, Large Adult	Mask, Face, Large Adult - 167000	FDA UDI	Class I	Active
Disposable PFT Nose Clip with Foam Pads	Foam Pad nose clip - 166527	FDA UDI	Class I	Active
ABSORBENT, CO2, Carbolime	ABSORBENT, CO2, Carbolime - 111301	FDA UDI	Class I	Active
PFT Kit E, VBMax28E, w/ Foam Nose Clip	PFT Kit E, VBMax28E - 189129	FDA UDI	Class II	Active
VBMax31	VBMax31 - Cosmed 156733	FDA UDI	Class II	Active
A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44	K991541	FDA 510(k)	Class II	Active
Large Centrifugal Blood Pump, Model Cp-2	K020529	FDA 510(k)	Class II	Active
Heparin Coated Miniature Centrifugal Bypass Pump System;model #cp-1h	K013393	FDA 510(k)	Class II	Active
Vbmax	K000654	FDA 510(k)FDA UDI	Class II	Active
A-M Systems Viromax Viral And Bacterial Filter	K063526	FDA 510(k)	Class II	Active
Service Deionization Syst/Di Tank Exchange Program	K915258	FDA 510(k)	Class II	Active
A-Miniature Centrifugal Blood Pump System, Model Cpb 2000	K992592	FDA 510(k)	Class II	Active

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FDA Recalls (2)

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
Aug 10, 2018	Z-0120-2019	—	terminated	Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
Mar 31, 2010	Z-0308-2012	—	terminated	Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.