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Vapotherm
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref PROSOFT-NEOModel ProSoft High Velocity Nasal Cannula
Identity
- Trade Name
- ProSoft EUDAMEDVapotherm FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- ProSoft High Velocity Nasal Cannula EUDAMEDProSoft, Neonate FDA UDI
- Model / Reference
- ProSoft-Neo EUDAMEDFDA UDIProSoft High Velocity Nasal Cannula EUDAMED
- Description
- ProSoft, Neonate FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841737103196 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841737102014UR EUDAMED
- Direct Marketing DI
- 00841737103196 EUDAMED
- FDA Product Code
- CAT FDA UDI
- EMDN Code
- R03010299 OXYGEN THERAPY MASKS AND NASAL CANNULAS - OTHER EUDAMED
- GMDN Term
- Nasal oxygen cannula, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5340 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Nasal oxygen cannula, basic
Vapotherm by Vapotherm Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nasal oxygen cannula, basic.
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- HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- Fisher and Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- BF — Allied Medical LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vapotherm Inc.
Sources (2)
- FDA UDI 8c101e73-b01b-4d9d-9742-fdbaeb7de1e7 33 fields · synced Jun 19, 2026
- EUDAMED c0143639-3346-4c4a-8f11-6ffe975989b0 61 fields · synced Jun 19, 2026