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PEEP Valve, 5~20 cmH2O, 30F
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AV0004Model (L) Resuscitator
Identity
- Trade Name
- PEEP Valve, 5~20 cmH2O, 30F EUDAMEDN/A FDA UDI
- Generic Name
- PEEP valve, single-use FDA UDI
- Device Name
- PEEP Valve EUDAMED
- Model / Reference
- (L) Resuscitator EUDAMEDAV0004 EUDAMED2423 FDA UDI
Identifiers
- Catalog Number
- 5-20cm HO, 30mmID, Blue FDA UDI
- Primary DI / UDI-DI
- 04710810080159 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNL482 EUDAMED
- FDA Product Code
- BYE FDA UDI
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS 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, 5~20 cmH2O, 30F 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 | 471081008NNL482 | 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 cb83c214-3abc-4ce7-9dff-e638da884c40 61 fields · synced Jun 19, 2026
- FDA UDI 6e9d6724-e39c-46b2-b88f-7558b7a090d6 34 fields · synced May 30, 2026