Adult Smoothbore Single Limb H/W B/c Kit 1.6M (63") (Kit 1)

GUDID 05055788708599

FLEXICARE MEDICAL LIMITED

Ventilator breathing circuit, single-use
Primary Device ID05055788708599
NIH Device Record Key8ce81832-de37-4248-90fd-8c581569c425
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult Smoothbore Single Limb H/W B/c Kit 1.6M (63") (Kit 1)
Version Model Number038-31-601U
Company DUNS504406273
Company NameFLEXICARE MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055788708599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2016-10-04

Devices Manufactured by FLEXICARE MEDICAL LIMITED

15055788722462 - BriteBlade Pro Evo Single-Use Fiber Optic Miller 42024-08-15
15055788722486 - BriteBlade Pro Evo Single-Use Fiber Optic Miller 32024-08-15 BriteBlade Pro Evo Single-Use Fiber Optic Miller 3
15055788722509 - BriteBlade Pro Evo Single-Use Fiber Optic Miller 22024-08-15 BriteBlade Pro Evo Single-Use Fiber Optic Miller 2
15055788722523 - BriteBlade Pro Evo Single-Use Fiber Optic Miller 12024-08-15
15055788722561 - BriteBlade Pro Evo Single-Use Fiber Optic Mac 42024-08-15
15055788722585 - BriteBlade Pro Evo Single-Use Fiber Optic Mac 22024-08-15
15055788722608 - BriteBlade Pro Evo Single-Use Fiber Optic Mac 12024-08-15 BriteBlade Pro Evo Single-Use Fiber Optic Mac 1
15055788722622 - BriteBlade Pro Evo Single-Use Fiber Optic Mac 12024-08-15 BriteBlade Pro Evo Single-Use Fiber Optic Mac 1

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.