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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: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (434)

Page 3 of 9

Device	Model / Reference	Registries	Class	Status
VBMax35s, PF Testing Filter Labeled DR Burton	VBMax35s, DR Burton - 136504	FDA UDI	Class II	Active
Tubing, Smooth Interior, Disposable, 22MM-24"	Tubing, Smooth Interior, Disposable, 22MM-24" - 243203	FDA UDI	Class I	Active
VBMax	VBMax31S - 136700	FDA UDI	Class II	Active
Disposable PFT Kit, VBMax35S w/ Rubber Nose Clip	PFT Kit J, VBMax35S - 187145	FDA UDI	Class II	Active
Syringe, Calibration, 3 Liter, Aluminum, Custo-Med	Syringe, Calibration, 3 Liter, Aluminum, Custo-Med	FDA UDI	Class I	Active
Mouthpiece, Disposable, 1-3/16" O.D., 2.625" L	Mouthpiece, 1-3/16" O.D., 2.625" L - 162600	FDA UDI	Class I	Active
Mouthpiece, Disposable, 1 1/16" OD, 3.25" L	Mouthpiece, 1 1/16" OD, 3.25" L - 162900	FDA UDI	Class I	Active
Adapter, Cosmed Quark RMR To VBMax31	Adapter, Cosmed Quark RMR To VBMax31 - 115530	FDA UDI	Class I	Active
Tubing, End Fitting, 1 3/8" I.D. TO 1 1/2" Tubing	Tubing, End Fitting, 1 3/8" I.D. TO 1 1/2" Tubing - 270600	FDA UDI	Class I	Active
VBMax PFT Kit I	VBMax PFT Kit I - 187165	FDA UDI	Class II	Active
Sample, Adapter, Tube, Blue Reusable, 1 3/8 TO 1 1/8	Sample, Adapter, 1 3/8 TO 1 1/8 - 113899	FDA UDI	Class I	Active
Breathebite Mouthpiece	Breathebite Mouthpiece - 164951	FDA UDI	Class I	Active
Mouthpiece, Disposable, 1-3/8" O.D., 2.625" L	Mouthpiece, 1-3/8" O.D., 2.625" L - 162800	FDA UDI	Class I	Active
VBMax48	VBMax48 - 156807	FDA UDI	Class II	Active
Adapter, Tube, Plexiglas, 1 3/8" To 7/8" O.D.	Adapter, Plexiglas, 1 3/8" - 7/8" O.D. - 115000	FDA UDI	Class I	Active
VBMax	VBMax36E - 146600	FDA UDI	Class II	Active
PFT Kit B, VBMax48	PFT Kit B, VBMax48 - 188102	FDA UDI	Class II	Active
Mask, Face, Pediatric, w/o Valve, Spider	Mask, Face, Pediatric, w/o Valve - 167300	FDA UDI	Class I	Active
Syringe, Calibration, 3 Liter, Aluminum, Plain White	Syringe, Calibration, 3 Liter, Aluminum, Plain White - 192714	FDA UDI	Class I	Active
VBMax30E, PF Testing Filter	VBMax30E - 146304	FDA UDI	Class II	Active
VBMax	VBMax35E - 146507	FDA UDI	Class II	Active
PFT Kit A, 33 MM O.D. w. Foam Nose Clips	PFT Kit A, 33 MM O.D. - 183111	FDA UDI	Class II	Active
PFT Kit B	PFT Kit B - 180052	FDA UDI	Class II	Active
Tubing, Smooth Interior, Disposable, 1.500"-36"	Tubing, Smooth Interior, Disposable, 1.500"-36" - 244200	FDA UDI	Class I	Active
Pulmonary Function Test Kit J, VBMax30S	Pulmonary Function Test Kit J, VBMax30S - 187190	FDA UDI	Class II	Active
PFT Kit G, VBMax35E	PFT Kit G, VBMax35E - 189155	FDA UDI	Class II	Active
Mouthpiece, Disposable, IPPB Plastic, 22MM OD, 18 MM ID	Mouthpiece, IPPB, 22MM OD-18 MM ID - 163401	FDA UDI	Class I	Active
Tubing, End Fitting, 1 1/8" I.D. TO 1 1/8" Tubing	Tubing, End Fitting, 1 1/8" I.D. TO 1 1/8" Tubing - 270200	FDA UDI	Class I	Active
PFT Kit C, 48 MM O.D.	PFT Kit C, 48 MM O.D. - 188103	FDA UDI	Class II	Active
Disposable Blue PFT Nose Clip with Foam Pads	Disposable Blue PFT Nose Clip with Foam Pads - 166904	FDA UDI	Class I	Active
Option Home w/ Side Stream, Disposable Nebulizer	Option Home w/ Side Stream, Disposable Nebulizer - 166320	FDA UDI	Class I	Active
PFT Kit E, VBMax36E, with Blue Rubber Nose Clip	PFT Kit E, VBMax36E - 189116	FDA UDI	Class II	Active
Tubing, Smooth Interior, Hytrel, IMC, 22MM-72"	Tubing, Smooth Interior, Hytrel, IMC, 22MM-72"- 253500	FDA UDI	Class I	Active
Adapter, Tube, Thermoplastic Rubber 22 mm I.D.	Adapter, Tube, Thermoplastic Rubber 22 mm I.D. - 113900	FDA UDI	Class I	Active
Disposable PFT Nose Clip with Rubber Pads	Disposable PFT Nose Clip with Rubber Pads - 166000	FDA UDI	Class I	Active
ViroMax Bacterial/Viral Filter	ViroMax Filter Sample - 156299	FDA UDI	Class II	Active
VBMax48	VBMax48 - 156808	FDA UDI	Class II	Active
Mouthpiece, Disposable, 1-1/16" O.D., 2.625" L	Mouthpiece, 1-1/16" O.D., 2.625" L - 162402	FDA UDI	Class I	Active
Tubing, Smooth Interior, Disposable, 1.375"-12"	Tubing, Smooth Interior, Disposable, 1.375"-12" - 243000	FDA UDI	Class I	Active
Adapter, Tube, Autoclavable, 1 1/8 TO 7/8	Adapter, Tube, Autoclavable, 1 1/8 TO 7/8 - 113400	FDA UDI	Class I	Active
VBMax	VBMax34E - 146400	FDA UDI	Class II	Active
Chart Paper, Thermo Sensitive, Z-Folded, for SP-1 & AT-1	Chart Paper, Thermo Sensitive - 139400	FDA UDI	Class I	Active
PFT KIT F, DISPOSABLE, QTY 100, VBMax35E	PFT KIT F, VBMax35E - 189145	FDA UDI	Class II	Active
Pft Kit A, Disposable, Qty 100, 31 Mm O.d.	PFT KIT A - 182101	FDA UDI	Class II	Active
Mouthpiece, Reusable, Blue Thermoplastic	Mouthpiece, Reusable - 164000	EUDAMEDFDA UDI	Class I	Active
VBMax	VBMax33 - 156410	FDA UDI	Class II	Active
Tubing, Oxygen, 7 Feet, 2 Connectors	Tubing, Oxygen, 7 Ft, 2 Connectors - 166800	FDA UDI	Class I	Active
PFT Kit E, VBMax35E w/ Foam Nose Clip	PFT Kit E, VBMax35E - 189137	FDA UDI	Class II	Active
VBMax	VBMax31E - 146700	FDA UDI	Class II	Active
Mouthpiece, Disposable, IPPB Plastic	Mouthpiece, Disposable, IPPB - 163400	FDA UDI	Class I	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.