Venticaire Lite

FDA UDI

Class I (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name: Venticaire Lite FDA UDI
Generic Name: Rebreathing oxygen face mask FDA UDI
Device Name: Adult Medium Concentration Mask PVC Free with Head Strap and 3.0m Oxygen Tubing FDA UDI
Model / Reference: 033-10-002/1U FDA UDI
Description: Adult Medium Concentration Mask PVC Free with Head Strap and 3.0m Oxygen Tubing FDA UDI

Identifiers

Primary DI / UDI-DI: 05055931126485 FDA UDI
FDA Product Code: BYG FDA UDI
GMDN Term: Rebreathing oxygen face mask FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5580 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Rebreathing oxygen face mask

Venticaire Lite by Flexicare Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
Respireo Primo N Non Vented — Air Liquide Medical Systems S.r.l. · Class IIa
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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 I	Pending data

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Manufacturer

Manufacturer: Flexicare Medical Limited

Sources (1)

FDA UDI aab8489e-a450-47b0-8b43-37f74d81614e 33 fields · synced Jun 1, 2026