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Dual Mask-Paediatric Mc Male W/Co2 Monitoring W/Filter (usa)

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name
DUAL MASK-PAEDIATRIC MC MALE W/CO2 MONITORING W/FILTER (USA) FDA UDI
Generic Name
Rebreathing oxygen face mask FDA UDI
Model / Reference
032-12-145U FDA UDI

Identifiers

Primary DI / UDI-DI
05055788754749 FDA UDI
FDA Product Code
CCK FDA UDI
GMDN Term
Rebreathing oxygen face mask FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rebreathing oxygen face mask

Dual Mask-Paediatric Mc Male W/Co2 Monitoring W/Filter (usa) by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Rebreathing oxygen face mask.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 812153cb-8902-4db6-bf91-336616a55d02 32 fields · synced May 30, 2026