Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

A-Med Systems, Inc.

US

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 8 of 9
DeviceModel / ReferenceRegistriesClassStatus
Mouthpiece, Disposable, 1-1/4" O.D., 2.625" L Mouthpiece,1-1/4" O.D., 2.625" L - 163002
FDA UDI
Class IActive
VBMax VBMax36S - 136607
FDA UDI
Class IIActive
Innospire Mini Nebulizer, Compressor, Innospire Mini, Standard - 166310
FDA UDI
Class IActive
PFT Kit C, 36MM O.D. PFT Kit C, 36MM O.D. - 180665
FDA UDI
Class IIActive
Tubing, Smooth Interior, Hytrel, IMC, 22MM-60" Tubing, Smooth Interior, Hytrel, IMC, 22MM-60" - 253400
FDA UDI
Class IActive
PFT Kit I, VBMax36S PFT Kit I, VBMax36S, 187166
FDA UDI
Class IIActive
PFT Kit K, VBMax35S PFT Kit K, VBMax35S - 187155
FDA UDI
Class IIActive
Chart, X-Ref Ohio Med 617-0020-300, 5" x 200', 8L Chart, X-Ref Ohio Med 617-0020-300 - 139200
FDA UDI
Class IActive
PFT Kit F, VBMax34e, w/ Blue Foam Noseclip PFT Kit F, VBMax34e - 189194
FDA UDI
Class IIActive
Pulmonary Function Test Kit J, VBMax 30s Pulmonary Function Test Kit J - 187170
FDA UDI
Class IIActive
VBMax28, PF Testing Filter VBMax28, PF Testing Filter - 156904
FDA UDI
Class IIActive
PFT KIT F, 31 MM, e-Series, / Blue Foam Nose Clips 189191
FDA UDI
Class IIActive
Mouthpiece, Disposable, 1.125" ID, 2.5" L Mouthpiece, Disposable, 1.125" ID, 2.5" L - 168202
FDA UDI
Class IActive
Column, Ascarite, Disposable, 3.5 In Column, Ascarite, Disposable, 3.5 In - 152801
FDA UDI
Class IActive
Nebulizer, Hand Held Nebulizer, Hand Held - 166305
FDA UDI
Class IActive
VBMax VBMax48 - 156800
FDA UDI
Class IIActive
VBMax VBMax30L - 156301
FDA UDI
Class IIActive
Pulmonary Function Test Kit E Pulmonary Function Test Kit E - 189124
FDA UDI
Class IIActive
VBMax35E VBMax35E - 146508
FDA UDI
Class IIActive
Mouthpiece, Disposable, 1.045" O.D., 2.625" L Mouthpiece,1.045" O.D., 2.625" L - 163700
FDA UDI
Class IActive
Nebulizer, Hand Held, Tee Adapter Nebulizer, Hand Held, Tee Adapter - 166200
FDA UDI
Class IActive
VBMax VBMax36E - 146607
FDA UDI
Class IIActive
PFT Kit E, VBMax36E w/ Foam Nose Clip PFT Kit E, VBMax36E - 189138
FDA UDI
Class IIActive
VBMax36S, PF Testing Filter Labeled DR Burton VBMax36S, PF Testing Filter - 136604
FDA UDI
Class IIActive
Nebulizer, Side Stream, Disposable Nebulizer, Side Stream, Disposable - 166110
FDA UDI
Class IActive
Disposable Thermoplastic Mouthpiece Disposable Thermoplastic Mouthpiece - 164907
FDA UDI
Class IActive
Mouthpiece, Disposable, 1.045" O.D., 2.625" L Mouthpiece,1.045" O.D., 2.625" L - 163702
FDA UDI
Class IActive
Mouthpiece, 0.86" OD, 2.00" L for Old Peak Flow Meter Mouthpiece, 0.86" OD, 2.00" L - 161900
FDA UDI
Class IActive
VBMax35 VBMax35 - 156507
FDA UDI
Class IIActive
PFT KIT B, 36 mm PFT KIT B, 36 mm - 184102
FDA UDI
Class IIActive
3 Liter Aluminum Calibration Syringe w/ Adapter 3 Liter Calibration Syringe - 192711
FDA UDI
Class IActive
PFT Kit A w/ Foam Noseclip PFT Kit A w/ Foam Noseclip - 180054
FDA UDI
Class IIActive
Mouthpiece, Disposable, 1-5/16" O.D., 2.625" L Mouthpiece, 1-5/16" O.D., 2.625" L - 162702
FDA UDI
Class IActive
PFT Kit J, VBMax31S PFT Kit J, VBMax31S - 187141
FDA UDI
Class IIActive
Mouthpiece, Disposable, 1.01 OD, 2.625" L Mouthpiece,1.01 OD, 2.625" L - 163302
FDA UDI
Class IActive
VBMax28s, PF Testing Filter Labeled DR Burton VBMax28s, DR Burton - VBMax28s
FDA UDI
Class IIActive
Tubing, Smooth Interior, Disposable Disp. Smooth Interior Tubing - 243800
FDA UDI
Class IActive
VBMax 48 VBMax 48 - 156820
FDA UDI
Class IIActive
Kit, Disposable, Breathing, w/ Foam Nose Clip Kit, Disposable, Breathing - 180016
FDA UDI
Class IIActive
PFT Kit B, 33mm OD Kit PFT Kit B, 33mm OD Kit - 183114
FDA UDI
Class IIActive
VBMax35E, PF Testing Filter VBMax35E, PF Testing Filter - 146504
FDA UDI
Class IIActive
PFT Kit E, VBMax31E, with Rubber Mouthpiece & Noseclip PFT Kit E, VBMax31E - 189131
FDA UDI
Class IIActive
PFT Kit F, VBMax34S, w/ Foam Nose Clip PFT Kit F, VBMax34S - 187142
FDA UDI
Class IIActive
Chart, X-Ref Collins Apex 22023, 11 x 19.625, Gum Chart, X-Ref Collins Apex 22023 - 133600
FDA UDI
Class IActive
VBMax36, PF Testing Filter VBMax36, PF Testing Filter - 156604
FDA UDI
Class IIActive
Syringe, Calibration, 3 Liter, Aluminum, Schiller-America Syringe, Calibration, 3 Liter, Aluminum, Schiller-America - 192707
FDA UDI
Class IActive
Adapter, Tube, Acrylic, 2" TO 1 3/8" Adapter, Acrylic, 2" TO 1 3/8" - 114200
FDA UDI
Class IActive
PFT KIT J, VBMax35S, w/ Foam Nose Clip PFT KIT J, VBMax35S - 187185
FDA UDI
Class IIActive
PFT Kit G, VBMax28E PFT Kit G, VBMax28E - 189178
FDA UDI
Class IIActive
PFT KIT J, VBMax34S w/ Blue Rubber Nose clip PFT KIT J, VBMax34S - 187174
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Aug 10, 2018Z-0120-2019—terminated

Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

Mar 31, 2010Z-0308-2012—terminated

Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.