Adult Dual Heated Wire Breathing Circuit 1.6M (63") (Kit 2)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Adult Dual Heated Wire Breathing Circuit 1.6M (63") (Kit 2) FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- Humidification Circuits EUDAMED
- Model / Reference
- 038-31-202U EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788708667 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055788708667 EUDAMED
- FDA Product Code
- BTT FDA UDIBZE FDA UDI
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5450 FDA UDI868.5270 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Ventilator breathing circuit, single-use
Adult Dual Heated Wire Breathing Circuit 1.6M (63") (Kit 2) by Flexicare Medical Limited — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (2)
- FDA UDI 7fba76da-781c-4d1f-b51d-09692282912a 32 fields · synced Oct 8, 2026
- EUDAMED 4936098e-c246-4713-ad90-41de2efec184 61 fields · synced Oct 8, 2026