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Sign in to claim this brandWhat GAMBRO INDUSTRIES makes
The company manufactures haemofilters and apheresis system filters for whole blood processing, as well as intravenous line filters. Their product portfolio includes sets like the PRISMAFLEX SET and PRISMAFLEX TPE 2000 SET, designed for renal dialysis and blood purification therapies, alongside the DIACLEAR filter for intravenous applications.
These devices are classified under FDA regulations as Class II and Class III, with unique device identifiers (UDI) listed in the FDA’s UDI database. The company operates under US regulatory oversight, ensuring compliance with medical device authorisation requirements 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 medical devices does Gambro Industries manufacture?
Gambro Industries specialises in haemofilters, apheresis system filters for whole blood processing, and intravenous line filters. Their products are primarily used in renal dialysis, blood purification therapies, and intravenous applications, such as the PRISMAFLEX SET series and the DIACLEAR filter.
Where is Gambro Industries based, and under which regulatory framework do its devices operate?
Gambro Industries is based in the United States. Its devices are subject to FDA regulatory oversight, meaning they must comply with US medical device authorisation requirements to be legally marketed.
Which regulatory registries list Gambro Industries’ devices?
Gambro Industries’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for Class II and Class III devices under US regulations.
How are Gambro Industries’ devices classified under FDA regulations?
Gambro Industries’ devices fall into two FDA classification categories: Class II and Class III. Class II devices generally pose moderate risk and require special controls beyond general controls, while Class III devices are higher risk and typically require pre-market approval due to insufficient data to ensure safety and effectiveness through other means.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- baxter.com
- —
- —
- [email protected]
- Phone
- +1(800)933-0303
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 393020474
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Prismaflex Set | 107636US | FDA UDI | Class II | Active |
| Prismaflex Set | HF1000 | FDA UDI | Class II | Active |
| Prismaflex Set | M150 | FDA UDI | Class II | Active |
| Diaclear | 106887 | FDA UDI | Class II | Active |
| Prismaflex Set | 107643US | FDA UDI | Class II | Active |
| Prismaflex Set | M60 | FDA UDI | Class II | Active |
| Prismaflex Set | HF1400 | FDA UDI | Class II | Active |
| Prismaflex Tpe 2000 Set | 114093 | FDA UDI | Class III | Active |
| Prismaflex Set | M100 | FDA UDI | Class II | Active |
| Prismaflex Set | 107640US | FDA UDI | Class II | Active |
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