Venticaire Lite

GUDID 05055931126485

Adult Medium Concentration Mask PVC Free with Head Strap and 3.0m Oxygen Tubing

FLEXICARE MEDICAL LIMITED

Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask
Primary Device ID05055931126485
NIH Device Record Keyaab8489e-a450-47b0-8b43-37f74d81614e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenticaire Lite
Version Model Number033-10-002/1U
Company DUNS504406273
Company NameFLEXICARE MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055931126485 [Primary]

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-25
Device Publish Date2024-03-15

On-Brand Devices [Venticaire Lite]

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05055931127819Pediatric Dual Mask Combined O2 Delivery / CO2 Monitoring Male Luer + 2.1m Oxygen Tubing
05055931127802Pediatric Dual Mask Combined O2 Delivery / CO2 Monitoring Female Luer + 2.1m Oxygen Tubing
05055931127796Adult Dual Mask Combined O2 Delivery / CO2 Monitoring Microstream type Luer & filter & 3m O2 Tub
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05055931127772Adult Dual Mask Combined O2 Delivery / CO2 Monitoring, Male Luer and filter with 3m Oxygen Tubin
05055931127765Adult Dual Mask Combined O2 Delivery / CO2 Monitoring Male Luer and filter with 2.1m Oxygen Tubi
05055931127758Adult Dual Mask Combined O2 Delivery / CO2 Monitoring, Female Luer & filter with 3m Oxygen Tubin
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05055931127734Adult Dual Mask Combined O2 Delivery / CO2 Monitoring Male Luer + 2.1m Oxygen Tubing
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