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Hi-oxygen mask adult non-rebreathing reservoir bag with 7ft Tube(universal conne
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Hi-oxygen mask adult non-rebreathing reservoir bag with 7ft Tube(universal conne FDA UDI
- Generic Name
- Respiratory oxygen therapy system FDA UDI
- Device Name
- Hi-oxygen mask adult non-rebreathing reservoir bag with 7ft Tube(universal connetor on one FDA UDI
- Model / Reference
- OM-81217 FDA UDI
- Description
- Hi-oxygen mask adult non-rebreathing reservoir bag with 7ft Tube(universal connetor on one FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770812175 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
- 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
Category: Respiratory oxygen therapy system
Hi-oxygen mask adult non-rebreathing reservoir bag with 7ft Tube(universal conne by Besmed Health Business Corp. — Class I — MDD, FDA UDI — listed in FDA…
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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
- Besmed Health Business Corp.
Sources (2)
- FDA UDI 5695b60a-8f43-47c9-baf0-d827a6acd072 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026