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Ventilator Adult 1.6m (63") Circuit + Y-Piece + 2 x Ports + 1 x Water Trap (038
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Ventilator Adult 1.6m (63") Circuit + Y-Piece + 2 x Ports + 1 x Water Trap (038 FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- Ventilator Adult 1.6m (63") Circuit + Y-Piece + 2 x Ports + 1 x Water Trap (038-01-150GE) FDA UDI
- Model / Reference
- 2105488-017 FDA UDI
- Description
- Ventilator Adult 1.6m (63") Circuit + Y-Piece + 2 x Ports + 1 x Water Trap (038-01-150GE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788777038 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Ventilator breathing circuit, single-use
Ventilator Adult 1.6m (63") Circuit + Y-Piece + 2 x Ports + 1 x Water Trap (038 by Flexicare Medical Limited — Class I — MDD, FDA UDI — listed in FDA GUDID…
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (2)
- FDA UDI ed30ed62-48d9-444b-a92f-b6049ad0901f 33 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced Sep 17, 2026