Identity
- Trade Name
- Newport FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Device Name
- E360T VENT, TS, US DEMO LOANER FDA UDI
- Model / Reference
- DLE360T-US-NA FDA UDI
- Description
- E360T VENT, TS, US DEMO LOANER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521208957 FDA UDI
- 510(k) Number
- K101803 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Neonatal/adult intensive-care ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Neonatal/adult intensive-care ventilator
Newport by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neonatal/adult intensive-care ventilator.
- Aeroneb Module control cable — Maquet Critical Care AB · Class II
- VMAX — VYAIRE MEDICAL, INC. · Class II
- Neumovent — Tecme Corporation · Class II
- AVEA II — VYAIRE MEDICAL, INC. · Class II
- AVEA™ — VYAIRE MEDICAL, INC. · Class II
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI af4b5c50-92d0-4b4a-9d6a-e585c0adb46e 35 fields · synced May 30, 2026