Identity
- Trade Name
- Newport Medical FDA UDI
- Generic Name
- Carbon dioxide cuvette, single-use FDA UDI
- Device Name
- KIT, PED/ ADULT AIRWAY FLOW SENSOR, BOX OF 4 FDA UDI
- Model / Reference
- KIT3420A FDA UDI
- Description
- KIT, PED/ ADULT AIRWAY FLOW SENSOR, BOX OF 4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521544444 FDA UDI
- 510(k) Number
- K111146 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Carbon dioxide cuvette, single-use 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carbon dioxide cuvette, single-use
Newport Medical by Newport Medical Instruments — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Carbon dioxide cuvette, single-use.
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- Disposable CO2 Cuvette paed. — Drägerwerk AG & Co. KGaA · Class II
- Respiratory Mechanics Sensor – Neonatal — Draeger Medical Systems, Inc. · Class II
- Newport — Covidien LP · Class II
- Airway Adapters — Respironics Novametrix, LLC · Class I
- Respiratory Mechanics Combined Flow/CO2 Sensor – Adult/pediatric — Draeger Medical Systems, Inc. · 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 |
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Manufacturer
- Manufacturer
- Newport Medical Instruments
Sources (1)
- FDA UDI 0a915ddd-25f9-49a8-a1d7-ddb352ca3e38 35 fields · synced May 30, 2026