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Vital Signs™ Breathing Circuit, Pediatric Disposable 3.75m/150in With Manual Ba…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M1218013
Identity
- Trade Name
- Vital Signs™ Breathing Circuit, Pediatric Disposable 3.75m/150in With Manual Bag, 1 L, Gas Sampling Elbow, HMEF 750/S and Gas Sampling Line, 6 m EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- Vital Signs™ Breathing Circuits, w/o Water Trap EUDAMEDVital Signs™ Breathing Circuit, Pediatric Disposable 3.75m/150in With Manual Bag, 1 L, Gas Sampling Elbow, HMEF 750/S and Gas Sampling Line, 6 m FDA UDI
- Model / Reference
- M1218013 EUDAMEDFDA UDI
- Description
- Vital Signs™ Breathing Circuit, Pediatric Disposable 3.75m/150in With Manual Bag, 1 L, Gas Sampling Elbow, HMEF 750/S and Gas Sampling Line, 6 m FDA UDI
Identifiers
- Catalog Number
- M1218013 FDA UDI
- Primary DI / UDI-DI
- 10889483603574 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10889483603574 EUDAMED
- 510(k) Number
- K031653 FDA UDI
- FDA Product Code
- CAH FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5260 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Vital Signs™ Breathing Circuit, Pediatric Disposable 3.75m/150in With Manual Ba… 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-10889483603574 | 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 6c870a97-d96b-48d8-a39e-63889a5b926c 61 fields · synced Oct 8, 2026
- FDA UDI f9b3bd79-8e4e-4dc5-8d6e-c98bcb919f1b 36 fields · synced May 30, 2026