My Penguin Compressor Nebulizer

GUDID 00840117300026

DYNAREX CORPORATION

Nebulizing system, non-heated
Primary Device ID00840117300026
NIH Device Record Keydea6573c-9646-4350-b7e2-eba5159a6302
Commercial Distribution StatusIn Commercial Distribution
Brand NameMy Penguin Compressor Nebulizer
Version Model Number5608PN
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
GS100616784560847 [Unit of Use]
GS100840117300026 [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 Date2019-12-26
Device Publish Date2019-12-18

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