Hygrovent Child Straight Bacterial Viral HMEF

GUDID 05055788778233

FLEXICARE MEDICAL LIMITED

Heat/moisture exchanger/microbial medical gas filter
Primary Device ID05055788778233
NIH Device Record Key5505e816-aadd-4524-9cc6-f058b933b6de
Commercial Distribution StatusIn Commercial Distribution
Brand NameHygrovent Child Straight Bacterial Viral HMEF
Version Model Number303-520-000
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055788778233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-12-22
Device Publish Date2020-03-25

On-Brand Devices [Hygrovent Child Straight Bacterial Viral HMEF]

05055788792161301-520-000U
05055788778233303-520-000

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