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Durable Peep-Valve, 2-10 cmH2O, ID: 30mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RE-21330
Identity
- Trade Name
- DURABLE PEEP VALVE 2-10cmH2O, ORANGE, ID:30mm FDA UDI
- Generic Name
- PEEP valve, reusable FDA UDI
- Device Name
- Durable Peep-Valve, 2-10 cmH2O, ID: 30mm EUDAMED
- Model / Reference
- RE-21330 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- D-RE-21330Y3 EUDAMED04716770213309 FDA UDI
- Basic UDI-DI
- B-RE-21330Y3 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, reusable 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
No
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
Durable Peep-Valve, 2-10 cmH2O, ID: 30mm by Besmed Health Business Corp. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
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- SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
- Ventlab — Ventlab Corp. · Class I
- Ventlab — Ventlab Corp. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-RE-21330Y3 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-RE-21330Y3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
- EUDAMED SRN
- TW-MF-000007246
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED bd613c76-ebe6-4183-87fe-4cb9916b4af9 61 fields · synced May 31, 2026
- FDA UDI 5d6304f3-e5b3-48ec-9849-5314250a9e46 33 fields · synced May 29, 2026