Disposable Manual Resuscitator
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Disposable Manual Resuscitator EUDAMEDCPR-2 Bag FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- Adult CPR Bag EUDAMED
- Model / Reference
- 10-55000 EUDAMED10-58506 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043585061 EUDAMEDFDA UDI
- Basic UDI-DI
- 0641043CPMT EUDAMED
- 510(k) Number
- K911622 FDA UDI
- FDA Product Code
- BTM FDA UDI
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
Yes
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Pulmonary resuscitator, manual, single-use
Disposable Manual Resuscitator by Mercury Medical — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
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- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
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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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0641043CPMT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 c1bdf210-5432-4bbc-83a0-8633ddbc4a76 61 fields · synced Jul 23, 2026
- FDA UDI 4ba7b131-c04c-493c-babe-c19d82862c47 34 fields · synced May 30, 2026