Identity
- Trade Name
- OAM EUDAMEDVapotherm FDA UDI
- Generic Name
- Respiratory oxygen therapy physiologic monitor/gas regulator FDA UDI
- Device Name
- Precision Flow Oxygen Assist Module EUDAMEDFDA UDI
- Model / Reference
- PF-OAM EUDAMEDFDA UDI
- Description
- Precision Flow Oxygen Assist Module FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841737103011 EUDAMED00841737103042 FDA UDI
- Basic UDI-DI
- B-00841737103011 EUDAMED
- FDA Product Code
- QAV FDA UDIBTT FDA UDI
- EMDN Code
- Z1203020499 GASEOUS EXCHANGE MONITORING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Respiratory oxygen therapy physiologic monitor/gas regulator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5454 FDA UDI868.5450 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
Yes
Measuring Function
Yes
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, manualRespiratory oxygen therapy physiologic monitor/gas regulatorRespiratory oxygen therapy pulse oximeter-regulator interface
Vapotherm by Vapotherm Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory oxygen therapy physiologic monitor/gas regulator.
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm 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
MDD
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 |
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Manufacturer
- Manufacturer
- Vapotherm Inc.
Sources (2)
- FDA UDI b27ea004-568e-4d07-b21a-dc20b4c66498 33 fields · synced Jul 20, 2026
- EUDAMED 9dedb800-d256-4fc6-8d01-45e455a5ed34 61 fields · synced Jul 20, 2026