Identity
- Trade Name
- EM FDA UDI
- Generic Name
- Emergency oxygen delivery kit FDA UDI
- Device Name
- MINILATOR, ST FDA UDI
- Model / Reference
- L543 FDA UDI
- Description
- MINILATOR, ST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00026072022511 FDA UDI
- 510(k) Number
- K860516 FDA UDI
- FDA Product Code
- BXY FDA UDI
- GMDN Term
- Emergency oxygen delivery kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2350 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Emergency oxygen delivery kit
Em by Allied Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Emergency oxygen delivery kit.
- EM — Allied Medical LLC · Class I
- EM — Allied Medical LLC · Class I
- EM — Allied Medical LLC · Class I
- EM — Allied Medical LLC · Class I
- EM — Allied Medical LLC · Class I
- EM — Allied Medical LLC · Class I
- EM — Allied Medical LLC · Class I
Cleared under the same submission
K860516 also covers:
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
- Allied Medical LLC
Sources (1)
- FDA UDI 54f1cac6-4434-4e83-a956-328a8b6f8da0 34 fields · synced May 31, 2026