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Vital Signs™ Breathing Bag, Disposable, 3L
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M1036388
Identity
- Trade Name
- Vital Signs™ Breathing Bag, Disposable, 3L EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Breathing circuit bag, single-use FDA UDI
- Device Name
- Vital Signs™ Anaesthesia Balloons EUDAMEDBreathing Bag, Disposable, 3 L FDA UDI
- Model / Reference
- M1036388 EUDAMEDFDA UDI
- Description
- Breathing Bag, Disposable, 3 L FDA UDI
Identifiers
- Catalog Number
- M1036388 FDA UDI
- Primary DI / UDI-DI
- 10190752108950 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10190752108950 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
- Finland 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vital Signs™ Breathing Bag, Disposable, 3L by AirLife Finland Oy — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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-10190752108950 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (2)
- EUDAMED b98b4eaf-8012-43ff-b839-0df341bf7646 61 fields · synced Jul 9, 2026
- FDA UDI b711a5e3-b249-459e-b84f-9d20adca469a 35 fields · synced May 30, 2026