Pediatric Compressor Nebulizer Bear

GUDID 00840117300040

DYNAREX CORPORATION

Nebulizing system, non-heated
Primary Device ID00840117300040
NIH Device Record Key380f9759-9879-4f22-825a-db86949b1233
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Compressor Nebulizer Bear
Version Model Number5608BR
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS100616784560823 [Unit of Use]
GS100840117300040 [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 Date2019-12-03
Device Publish Date2019-11-25

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