Pediatric Compressor Nebulizer Pig

GUDID 00840117300033

DYNAREX CORPORATION

Nebulizing system, non-heated
Primary Device ID00840117300033
NIH Device Record Key7563b868-b559-4533-89b7-30d5615b0ea1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Compressor Nebulizer Pig
Version Model Number5608PG
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
GS100616784560816 [Unit of Use]
GS100840117300033 [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

Devices Manufactured by DYNAREX CORPORATION

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00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm 2024-11-01 Sterile-EO
00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm 2024-11-01 Sterile-EO
00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm 2024-11-01 Sterile-EO
00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm 2024-11-01 Sterile-Eo
00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm 2024-11-01 Sterile-Eo
00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm2024-11-01 Sterile-Eo
00840117313026 - Resp-O2 Endotracheal Tube Cuffed, 7.0 mm 2024-11-01 Sterile-Eo

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