Identity
- Trade Name
- Vapotherm FDA UDI
- Generic Name
- Freestanding/bed-attached intravenous pole FDA UDI
- Device Name
- Precision Flow® Disposable Patient Circuits and Accessories EUDAMEDPF-Stand-E Replacement Kit FDA UDI
- Model / Reference
- PF-STAND-E EUDAMED3101925 FDA UDI
- Description
- PF-Stand-E Replacement Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841737103493 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841737102441VG EUDAMED
- FDA Product Code
- FOX FDA UDI
- EMDN Code
- Z12030399 INFUSION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Freestanding/bed-attached intravenous pole FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 880.6990 FDA UDI
- Market of Registration
- Austria 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
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
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: Freestanding/bed-attached intravenous pole
Vapotherm by Vapotherm Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Freestanding/bed-attached intravenous pole.
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- BV Medical — Medical, Inc. · Class I
- B-Braun — PRYOR PRODUCTS · 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 64f5422d-52ef-4fcb-81f8-771ccc8cd311 33 fields · synced Jul 19, 2026
- EUDAMED a8d89e05-e382-427b-a5e7-cb7146913dc8 61 fields · synced Jul 19, 2026