Bentely the Bear Pediatric Nebulizer

GUDID 00372217005049

Bentely the Bear Pediatric Nebulizer

ARISE MEDICAL LLC

Nebulizing system delivery set, reusable
Primary Device ID00372217005049
NIH Device Record Keyc0e3cbee-73bd-4a53-8116-2f3ff1cd70e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBentely the Bear Pediatric Nebulizer
Version Model Number240486
Company DUNS081149273
Company NameARISE MEDICAL LLC
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100372217005049 [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 Date2019-05-10
Device Publish Date2019-05-02

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