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PEEP Valve, 5~20cmH2O, 22F
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AV0038Model (H) Ventilation Circuit
Identity
- Trade Name
- PEEP Valve, 5~20cmH2O, 22F EUDAMEDN/A FDA UDI
- Generic Name
- PEEP valve, single-use FDA UDI
- Device Name
- Peep valve EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAV0038 EUDAMED2421 FDA UDI
Identifiers
- Catalog Number
- Disposable Adjustable Peep Valve 5-20cm H O, 22mmID, Blue FDA UDI
- Primary DI / UDI-DI
- 04710810083693 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNH47N EUDAMED
- FDA Product Code
- BYE FDA UDI
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER EUDAMED
- GMDN Term
- PEEP valve, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5965 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
PEEP Valve, 5~20cmH2O, 22F by GaleMed Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471081008NNH47N | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0c1fba83-04a2-413f-b975-ebc55f4f6750 61 fields · synced Jun 18, 2026
- FDA UDI 3186098d-fa1d-42df-8f7c-7b4b69750e96 34 fields · synced May 30, 2026