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Breathing bag Anesthesia, Disposable 0.5L
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6692215
Identity
- Trade Name
- Breathing bag Anesthesia, Disposable 0.5L EUDAMEDBreathing bag anest disp 0.5L,compl FDA UDI
- Generic Name
- Breathing circuit bag, single-use FDA UDI
- Device Name
- Breathing Bag Anesthesia EUDAMED
- Model / Reference
- 6692215 EUDAMED6694605 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07325710002520 EUDAMEDFDA UDI
- Basic UDI-DI
- 73257100022487 EUDAMED
- FDA Product Code
- BTC FDA UDI
- EMDN Code
- R03020101 ANAESTHESIA BALLOONS EUDAMED
- GMDN Term
- Breathing circuit bag, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5320 FDA UDI
- Market of Registration
- Sweden 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Breathing bag Anesthesia, Disposable 0.5L by Maquet Critical Care AB — Class IIa — 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 | 73257100022487 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Maquet Critical Care AB
- EUDAMED SRN
- SE-MF-000001264
Sources (2)
- EUDAMED d54394d1-95bb-4e63-a7e3-7de075473479 61 fields · synced Oct 6, 2026
- FDA UDI b169dd67-c799-4514-9e75-cc91745728dd 32 fields · synced May 30, 2026