Identity
- Trade Name
- Vapotherm FDA UDI
- Generic Name
- Professional high-flow respiratory unit, humidifying, manual FDA UDI
- Device Name
- Precision Flow® Disposable Patient Circuits and Accessories EUDAMEDAAA-1 FDA UDI
- Model / Reference
- AAA-1 EUDAMEDFDA UDI
- Description
- AAA-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841737100751 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841737102441VG EUDAMED
- Direct Marketing DI
- 00841737100751 EUDAMED
- FDA Product Code
- BTT FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Professional high-flow respiratory unit, humidifying, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5450 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Professional high-flow respiratory unit, humidifying, manual
Vapotherm by Vapotherm Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vapotherm Inc.
Sources (2)
- FDA UDI 14d791b7-8283-4417-b753-433ae7a79963 33 fields · synced Jul 9, 2026
- EUDAMED d35d273b-82e8-48ef-b74a-6d95c8f64dfb 61 fields · synced Jul 9, 2026