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 EUDAMEDAerosol Disposable Patient Circuit, High Flow FDA UDI
- Model / Reference
- PF-ADPC-High EUDAMEDFDA UDI
- Description
- Aerosol Disposable Patient Circuit, High Flow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841737102991 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841737102441VG EUDAMED
- Direct Marketing DI
- 00841737102991 EUDAMED
- FDA Product Code
- BTT FDA UDI
- EMDN Code
- R040201 TRACHEOSTOMY HUMIDIFIERS 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
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
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 87159a72-50c3-4807-a720-2829d2abfab4 33 fields · synced Jul 9, 2026
- EUDAMED e14e7e7d-bedc-4747-90d4-a1ec2a04cdce 61 fields · synced Jul 9, 2026