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 EUDAMEDDisposable Patient Circuit, Low Flow FDA UDI
- Model / Reference
- PF-DPC-LOW EUDAMEDFDA UDI
- Description
- Disposable Patient Circuit, Low Flow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841737100096 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841737102441VG EUDAMED
- Direct Marketing DI
- 00841737100096 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
- Austria 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
Similar devices
Also classified as Professional high-flow respiratory unit, humidifying, manual.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- Bonhawa Respiratory Humidifier — Telesair, Inc · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vapotherm Inc.
Sources (2)
- FDA UDI 8c8ee31f-c75f-4c99-8157-78e2bd1dcc1c 33 fields · synced Jul 12, 2026
- EUDAMED 90baa0b5-425c-4036-bf4a-6b0ab13e3bf0 61 fields · synced Jul 12, 2026