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Vital Signs™ Manual Ventilation Components for ABS Bag Arm, Disposable 0.9 m/36…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M1019519
Identity
- Trade Name
- Vital Signs™ Manual Ventilation Components for ABS Bag Arm, Disposable 0.9 m/36 in EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- Vital Signs™ Anaesthesia Balloons EUDAMEDManual Ventilation Components for ABS Bag Arm, Disposable 0.9 m/36 in FDA UDI
- Model / Reference
- M1019519 EUDAMEDFDA UDI
- Description
- Manual Ventilation Components for ABS Bag Arm, Disposable 0.9 m/36 in FDA UDI
Identifiers
- Catalog Number
- M1019519 FDA UDI
- Primary DI / UDI-DI
- 10190752136144 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10190752136144 EUDAMED
- FDA Product Code
- BTC FDA UDI
- EMDN Code
- R03020101 ANAESTHESIA BALLOONS EUDAMED
- GMDN Term
- Anaesthesia breathing circuit, 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
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
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™ Manual Ventilation Components for ABS Bag Arm, Disposable 0.9 m/36… by AirLife Finland Oy — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-10190752136144 | 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 6d63ed7c-8142-45b7-b36d-bc1d97c5f41f 61 fields · synced Jul 27, 2026
- FDA UDI 7804e048-c3db-4002-9b8a-616718e51f06 35 fields · synced May 30, 2026