Identity
- Trade Name
- MCN AIR Y1 DSF DSF S FDA UDI
- Generic Name
- Mixed-respiratory-gas low pressure hose FDA UDI
- Device Name
- Low-pressure hoses are intended for the transfer of medical gases or vacuum, and/or the connection of two medical products (e.g. a pressure regulator with an emergency ventilator). FDA UDI
- Model / Reference
- 0731017US FDA UDI
- Description
- Low-pressure hoses are intended for the transfer of medical gases or vacuum, and/or the connection of two medical products (e.g. a pressure regulator with an emergency ventilator). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08592346820944 FDA UDI
- FDA Product Code
- BYX FDA UDI
- GMDN Term
- Mixed-respiratory-gas low pressure hose FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Mixed-respiratory-gas low pressure hose
Mcn Air Y1 Dsf Dsf S by GCE, s.r.o. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GCE, s.r.o.
Sources (1)
- FDA UDI ee9cd8f7-42a2-481a-a42c-fc0afc5f9e3c 33 fields · synced Jun 1, 2026