Flexicare

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name: Flexicare FDA UDI
Generic Name: Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Device Name: Dual Adult Oral/Nasal Cannula14ftO2Delivery/CO2Monitoring/ExtendedUse/Filter/MicrostreamCompatible FDA UDI
Model / Reference: 032-10-181LU FDA UDI
Description: Dual Adult Oral/Nasal Cannula14ftO2Delivery/CO2Monitoring/ExtendedUse/Filter/MicrostreamCompatible FDA UDI

Identifiers

Primary DI / UDI-DI: 05055931127895 FDA UDI
FDA Product Code: CCK FDA UDI
CAT FDA UDI
GMDN Term: Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1400 FDA UDI
868.5340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Nasal oxygen cannula, carbon-dioxide-sampling

Flexicare by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nasal oxygen cannula, carbon-dioxide-sampling.

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Gas Sampling Lines — SALTER LABS · Class II
Microstream Advance — ORIDION MEDICAL 1987 LTD. · Class II
Omnistream — ORIDION MEDICAL 1987 LTD. · Class II
Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II

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: Flexicare Medical Limited

Sources (1)

FDA UDI 14f888e4-75e2-4696-93b3-198cb8114292 33 fields · synced May 30, 2026