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Sign in to claim this brandA-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
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- US
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Catalogue (434)
Page 7 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VBMax | VBMax28S - 136907 | FDA UDI | Class II | Active |
| PFT Kit A | PFT Kit A, Disposable, 30 MM O.D. - 181111 | FDA UDI | Class II | Active |
| Flow Tube, Easy One Air, Disposable | Flow Tube, Easy One Air, - 165750 | FDA UDI | Class I | Active |
| VBMax28, Disposable PF Testing Filter | VBMax28 - 156900 | FDA UDI | Class II | Active |
| Mouthpiece, Disposable, .900"OD, 2.50" L Assess Small | Mouthpiece, Disposable, .900"OD, 2.50" L - 168300 | FDA UDI | Class I | Active |
| PFT Kit B, 33 MM O.D. W/ White Foam Nose Clip | PFT Kit B, 33 MM O.D. W/ White Foam Nose Clip - 183112 | FDA UDI | Class II | Active |
| PFT Kit I | PFT Kit I, VBMax 36S, w/ White Foam Noseclips - 187126 | FDA UDI | Class II | Active |
| VBMax30S, PF Testing Filter Labeled DR Burton | VBMax30S - 136304 | FDA UDI | Class II | Active |
| PFT Kit A, 33 MM | PFT Kit A, 33 MM - 183101 | FDA UDI | Class II | Active |
| Tubing, Smooth Interior, Disposable, 1.98"X39" | Tubing, Smooth Interior, Disposable, 1.98"X39" - 245200 | FDA UDI | Class I | Active |
| Chart, X-Ref Breon 2206, 6.625" x 8", Green | Chart, X-Ref Breon 2206 - 131200 | FDA UDI | Class I | Active |
| VBMax34, PF Testing Filter Labeled DR Burton | VBMax34, PF Testing Filter - 156404 | FDA UDI | Class II | Active |
| Chart, X-Ref Collins Apex 22023 11" x 19.625", Grn | Chart, X-Ref Collins Apex 22023 - 133500 | FDA UDI | Class I | Active |
| PFT Kit C, 36 MM O.D. | PFT Kit C, 36 MM O.D. - 184103 | FDA UDI | Class II | Active |
| PFT Kit A, 48 MM O.D. | PFT Kit A, 48 MM O.D. - 188101 | FDA UDI | Class II | Active |
| VBMax34S | VBMax34S - 136407 | FDA UDI | Class II | Active |
| Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style | Disposable Mouthpiece, Bite Block Style - 164904 | FDA UDI | Class I | Active |
| Disposable Thermoplastic Mouthpiece | Disposable Thermoplastic Mouthpiece - 164900 | EUDAMEDFDA UDI | Class I | Active |
| Pft Kit A, 36 Mm O.d. | PFT KIT A, 36 MM O.D. - 184101 | FDA UDI | Class II | Active |
| VBMax34E, PF Testing Filter Labeled DR Burton | VBMax34E - 146404 | FDA UDI | Class II | Active |
| Mouthpiece, Disposable Lip Style, White | Mouthpiece, Disposable Lip Style, White - 164800 | FDA UDI | Class I | Active |
| Mouthpiece, Disposable, Flow Sensor | Mouthpiece, Disposable, Flow Sensor - 165900 | FDA UDI | Class I | Active |
| Chart Paper, Thermal, for Spirolab Spirometers | Chart Paper, Thermal, for Spirolab - 140700 | FDA UDI | Class I | Active |
| PFT Kit F, VBMax28S, w/ Rubber Mouthpiece | PFT Kit F, VBMax28S - 187178 | FDA UDI | Class II | Active |
| Syringe, Calibration, 3 Liter, Aluminum | Syringe, Calibration, 3 Liter, Aluminum - 192704 | FDA UDI | Class I | Active |
| Pulmonary Function Test Kit F | Pulmonary Function Test Kit F, 189174 | FDA UDI | Class II | Active |
| ViroMax | ViroMax - 156200 | FDA UDI | Class II | Active |
| Tubing, 1.125" I.D., 1 1/8"-1 3/8" Fittings, 28" L | Tubing, 1.125" I.D., 1 1/8"-1 3/8" Fittings, 28" L - 274600 | FDA UDI | Class I | Active |
| PFT Kit E, VBMax35E | PFT Kit E, VBMax35E - 189165 | FDA UDI | Class II | Active |
| PFT KIT F, VBMax36E, W/BLUE NOSE CLIP | PFT KIT F, VBMax36E, W/BLUE NOSE CLIP - 189176 | FDA UDI | Class II | Active |
| Mouthseal, Disposable, White Thermoplastic IPPB | Mouthseal, White Thermoplastic IPPB - 165400 | FDA UDI | Class I | Active |
| Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 34" L | Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 34" L - 278200 | FDA UDI | Class I | Active |
| Syringe, Calibration, Adj. Vol., Aluminum, MGC Diagnostics Logo | Syringe, Calibration, Adj. Vol., Aluminum, MGC Diagnostics Logo | FDA UDI | Class I | Active |
| Filter, Clear, Disposable, Viral/ Bacterial | Filter, Clear, Disposable,Viral/ Bacterial - 155200 | FDA UDI | Class II | Active |
| VBMax | VBMax35 - 156516 | FDA UDI | Class II | Active |
| Disposable Blue PFT Nose Clip with Rubber Pads | Disposable Blue PFT Nose Clip - 166704 | FDA UDI | Class I | Active |
| ndd Spirette Breathing Tube | ndd Spirette Breathing Tube - 165850 | FDA UDI | Class I | Active |
| Mouthpiece, Disposable Flex, 3/4" OD, 2.625" L | Mouthpiece,Flex, 3/4" OD, 2.625" L - 162103 | FDA UDI | Class I | Active |
| PFT Kit C | PFT Kit C - 180053 | FDA UDI | Class II | Active |
| VBMax | VBMax35E - 146500 | FDA UDI | Class II | Active |
| Mouthpiece, Disposable, 1.01 OD, 2.625" L | Mouthpiece,1.01 OD, 2.625" L - 163300 | FDA UDI | Class I | Active |
| VBMax35 E, Disposable PF Testing Filter | VBMax35 E - 146504 | FDA UDI | Class II | Active |
| Mouthpiece, Disposable, 1.058" O.D., 2.625" L | Mouthpiece,1.058" O.D., 2.625" L - 163800 | FDA UDI | Class I | Active |
| Column, Ascarite, Desiccator, Disposable | Column, Ascarite, Desiccator - 152900 | FDA UDI | Class I | Active |
| VBMax | VBMax30L - 156370 | FDA UDI | Class II | Active |
| Breathbite Mouthpiece, Disposable , Tongue Depressing | Breathbite Mouthpiece - 164950 | EUDAMEDFDA UDI | Class I | Active |
| Mouthpiece, Disposable, 1.035" O.D., 2.625" Length | Mouthpiece,1.035" O.D., 2.625" L - 163500 | FDA UDI | Class I | Active |
| Coupler, 22 MM O.D. TO 15 MM O.D. | Coupler, 22 MM O.D. TO 15 MM O.D. - 153800 | FDA UDI | Class I | Active |
| PFT Kit I, Disposable, VBMax31S, W/ Blue Rubber Nose Clips | PFT Kit I - 187111 | FDA UDI | Class II | Active |
| Nut and Nipple, Swivel, Green (Oxygen) | Nut and Nipple, Swivel - 155400 | FDA UDI | Class I | Active |
Related Companies
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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. |