Identity
- Trade Name
- Vapotherm FDA UDI
- Generic Name
- Professional high-flow respiratory unit, humidifying, manual FDA UDI
- Device Name
- Precision Flow Heliox Unit EUDAMEDPrecision Flow Heliox FDA UDI
- Model / Reference
- PFH-UNIT EUDAMEDFDA UDI
- Description
- Precision Flow Heliox FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841737101352 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841737101352 EUDAMED
- 510(k) Number
- K111640 FDA UDI
- 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Professional high-flow respiratory unit, humidifying, manual
Vapotherm by Vapotherm Inc. — Class II — MDD, 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
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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 717d077b-208b-4011-b799-d679921b1052 34 fields · synced Jul 20, 2026
- EUDAMED 20b74280-0936-4069-87ec-0eb62a14c149 61 fields · synced Jul 20, 2026