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Reusable CPR Bag
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 10-50706Model Reusable CPR BagRef 10-50718Ref 10-50735Ref 10-50734Ref 10-50705Ref 10-50700Ref 10-50707Ref 10-50732Ref 10-50731
Identity
- Device Name
- Reusable CPR Bag EUDAMED
- Model / Reference
- Reusable CPR Bag EUDAMED10-50706 EUDAMED10-50718 EUDAMED10-50735 EUDAMED10-50734 EUDAMED10-50705 EUDAMED10-50700 EUDAMED10-50707 EUDAMED10-50732 EUDAMED10-50731 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10641043507063 EUDAMED10641043507186 EUDAMED10641043507353 EUDAMED10641043507346 EUDAMED10641043507056 EUDAMED10641043507001 EUDAMED10641043507070 EUDAMED10641043507322 EUDAMED10641043507315 EUDAMED
- Basic UDI-DI
- 0641043CRMX EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Pulmonary resuscitator, manual, single-use
Reusable CPR Bag by Mercury Medical — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Pulmonary resuscitator, manual, single-use.
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- 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
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970756 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0641043CRMX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mercury Medical
- EUDAMED SRN
- US-MF-000002015
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (10)
- EUDAMED 244bf766-4ed3-4cbe-a57a-f9225e170263 61 fields · synced Aug 4, 2026
- EUDAMED bd21fb29-da30-4617-91ba-89ad7e83becd 61 fields · synced May 11, 2026
- EUDAMED 4a553cd1-4ff7-4699-be40-39fab29526ac 61 fields · synced May 16, 2026
- EUDAMED bf57dea3-6f20-4d56-a71d-0856653a995e 61 fields · synced May 16, 2026
- EUDAMED ed41782a-ad21-4eaa-94ba-bf5b2c187145 61 fields · synced May 17, 2026
- EUDAMED dad1adf2-ebac-41a0-b1c9-126c757e31e2 61 fields · synced May 17, 2026
- EUDAMED e9565d9a-d2bf-4b40-bc0c-9ce5868bfc13 61 fields · synced May 18, 2026
- EUDAMED 1e816641-a586-4816-a295-99ea4ed4d5f2 61 fields · synced May 18, 2026
- EUDAMED ee674242-30e2-45d1-9125-8bafe5fdfdba 61 fields · synced May 19, 2026
- FDA 510(k) K970756 1 fields · synced May 18, 2026