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PEEP Valve with Adapter
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10-55315Model 10-55310
Identity
- Trade Name
- PEEP Valve with Adapter EUDAMEDPEEP Valve FDA UDI
- Generic Name
- PEEP valve, single-use FDA UDI
- Device Name
- Positive End Expiratory Pressure (PEEP) VAlve EUDAMED
- Model / Reference
- 10-55310 EUDAMED10-55315 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043553152 EUDAMEDFDA UDI
- Basic UDI-DI
- 0641043PENC EUDAMED
- 510(k) Number
- K081266 FDA UDI
- FDA Product Code
- BYE FDA UDI
- EMDN Code
- R028001 RESPIRATORY CIRCUITS VALVES EUDAMED
- GMDN Term
- PEEP valve, single-use FDA UDI
Classification
- Device Class
- Class I 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
No
FDA UDI
MR Conditional FDA UDI
PEEP Valve with Adapter by Mercury Medical — Class I — 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 | 0641043PENC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mercury Medical
- EUDAMED SRN
- US-MF-000002015
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 622c29ad-2647-419d-af08-c92ff7e2f5dc 61 fields · synced Jul 9, 2026
- FDA UDI b89de06d-4438-469d-8d3c-0627785b2cd1 34 fields · synced May 30, 2026