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Disposable Peep-Valve 2-10 cmH2O, Orange color
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref RE-21310
Identity
- Trade Name
- DISPOSABLE PEEP VALVE 2-10cm H2O, ORANGE FDA UDI
- Generic Name
- PEEP valve, single-use FDA UDI
- Device Name
- Disposable Peep-Valve 2-10 cmH2O,Orange color EUDAMED
- Model / Reference
- RE-21310 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- D-RE-21310XV EUDAMED04716770213101 FDA UDI
- Basic UDI-DI
- B-RE-21310XV EUDAMED
- 510(k) Number
- K160112 FDA UDI
- 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
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Category: Pulmonary resuscitator, manual, single-use
Disposable Peep-Valve 2-10 cmH2O, Orange color by Besmed Health Business Corp. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160112 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-RE-21310XV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
- EUDAMED SRN
- TW-MF-000007246
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (3)
- EUDAMED 96d3383f-22b8-453c-91df-697cc9c323a7 61 fields · synced Oct 7, 2026
- FDA UDI a1374085-7a62-4612-a040-45f0474fe911 33 fields · synced May 30, 2026
- FDA 510(k) K160112 1 fields · synced May 18, 2026