Identity
- Trade Name
- Newport FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Device Name
- HT70 Ventilator With Accessories;O2 Monitor FDA UDI
- Model / Reference
- HT70M-WW-EU FDA UDI
- Description
- HT70 Ventilator With Accessories;O2 Monitor FDA UDI
Identifiers
- Catalog Number
- HT70M-WW-EU FDA UDI
- Primary DI / UDI-DI
- 10884521542136 FDA UDI
- 510(k) Number
- K111146 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
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 Newport Medical Instruments — 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
- Puritan Bennett — Covidien LP · Class II
- Neumovent — Tecme Corporation · Class II
- Puritan Bennett — Covidien LP · Class II
- AVEA II — VYAIRE MEDICAL, INC. · Class II
- AVEA™ — VYAIRE MEDICAL, INC. · Class II
- Puritan Bennett — Covidien LP · Class II
Cleared under the same submission
K111146 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newport Medical Instruments
Sources (1)
- FDA UDI 640e5be5-df7a-4f65-8799-75f694ca09de 37 fields · synced May 30, 2026