Identity
- Trade Name
- Newport FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Device Name
- LW AIR/O2 MIX W/GRNHS, DISS FT FDA UDI
- Model / Reference
- MXL70A-GR-DS FDA UDI
- Description
- LW AIR/O2 MIX W/GRNHS, DISS FT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521542334 FDA UDI
- 510(k) Number
- K860373 FDA UDI
- FDA Product Code
- BZR FDA UDI
- GMDN Term
- Neonatal/adult intensive-care ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5330 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neonatal/adult intensive-care ventilator
Newport by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neonatal/adult intensive-care ventilator.
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- Newport — Newport Medical Instruments · Class II
- V8800 Critical Care Ventilator — ORICARE INC. · Class II
- V8800 Critical Care Ventilator — ORICARE INC. · Class II
Cleared under the same submission
K860373 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 II | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 886f96b6-b10b-463b-bc14-dca80a3a1745 35 fields · synced May 30, 2026