Maxineb Duo Nebulizer + Mouthpiece And Filter

GUDID 05055931102014

FLEXICARE MEDICAL LIMITED

Nebulizing system, non-heated
Primary Device ID05055931102014
NIH Device Record Keyfd0fd87d-47f1-473e-8ac6-d7c32792b17d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaxineb Duo Nebulizer + Mouthpiece And Filter
Version Model Number032-10-034U
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
GS105055931102014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-06
Device Publish Date2020-03-27

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