Identity
- Trade Name
- Vapotherm FDA UDI
- Generic Name
- Electrical mains power cable FDA UDI
- Device Name
- HVT 2.0 Disposable Patient Circuit FDA UDI
- Model / Reference
- HVT-DPC FDA UDI
- Description
- HVT 2.0 Disposable Patient Circuit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841737103998 FDA UDI
- FDA Product Code
- QAV FDA UDIBTT FDA UDI
- GMDN Term
- Electrical mains power cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5454 FDA UDI868.5450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Respiratory oxygen sensorElectrical mains power cableProfessional high-flow respiratory unit, humidifying, manual
Vapotherm by Vapotherm Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vapotherm Inc.
Sources (1)
- FDA UDI 8397e35b-e343-4cd4-8309-4cb29799caf7 33 fields · synced Jun 8, 2026