Identity
- Trade Name
- Vapotherm FDA UDI
- Generic Name
- Negative-pressure face tent FDA UDI
- Device Name
- FELIX-1 FDA UDI
- Model / Reference
- FELIX-1 FDA UDI
- Description
- FELIX-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841737103608 FDA UDI
- GMDN Term
- Negative-pressure face tent FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Negative-pressure face tent
Vapotherm by Vapotherm Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure face tent.
- Vapotherm — Vapotherm Inc. · Class II
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vapotherm Inc.
Sources (1)
- FDA UDI 33d0fd54-10f5-4d09-93f1-a79d43730832 33 fields · synced May 30, 2026