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Hi-Oxygen Mask Adult, With 7ft Tube (universal Connector On One Side), Single Pa
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- HI-OXYGEN MASK ADULT, WITH 7FT TUBE (UNIVERSAL CONNECTOR ON ONE SIDE),SINGLE PA FDA UDI
- Generic Name
- Respiratory oxygen therapy system FDA UDI
- Device Name
- HI-OXYGEN MASK ADULT, WITH 7FT TUBE (UNIVERSAL CONNECTOR ON ONE SIDE),SINGLE PACKING FDA UDI
- Model / Reference
- OM-81211 FDA UDI
- Description
- HI-OXYGEN MASK ADULT, WITH 7FT TUBE (UNIVERSAL CONNECTOR ON ONE SIDE),SINGLE PACKING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770812113 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Respiratory oxygen therapy system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hi-Oxygen Mask Adult, With 7ft Tube (universal Connector On One Side), Single Pa by Besmed Health Business Corp. — Class I — FDA UDI — listed in FDA GUDID
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
- Besmed Health Business Corp.
Sources (1)
- FDA UDI 727ddf2a-2b2d-4999-8c3c-4ff7202fdba2 34 fields · synced Jun 1, 2026