Identity
- Trade Name
- NEW YORK PRESBYTERIAN HOSPITAL FDA UDI
- Generic Name
- Non-rebreathing oxygen face mask FDA UDI
- Device Name
- MASK OXYGEN-HIGH CONC-PEDS-ELONGATED-NBR-W/TUBING-7 FT UNIVERSAL CONNECTOR, 1/EA,50/CS FDA UDI
- Model / Reference
- 447009 FDA UDI
- Description
- MASK OXYGEN-HIGH CONC-PEDS-ELONGATED-NBR-W/TUBING-7 FT UNIVERSAL CONNECTOR, 1/EA,50/CS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216111226 FDA UDI
- FDA Product Code
- KGB FDA UDI
- GMDN Term
- Non-rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5570 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-rebreathing oxygen face mask
New York Presbyterian Hospital by Asp Global, LLC — 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
- Asp Global, LLC
Sources (1)
- FDA UDI 15afde3f-eb41-48f8-a9a7-9934d79741c0 33 fields · synced Jun 8, 2026