Respo-O2 Homecare Suction Unit, Portable, Batter Operated

GUDID 00840117326576

DYNAREX CORPORATION

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Primary Device ID00840117326576
NIH Device Record Keyae839688-97de-4998-8f51-05a24f3fdf37
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespo-O2 Homecare Suction Unit, Portable, Batter Operated
Version Model Number32305
Company DUNS008124539
Company NameDYNAREX CORPORATION
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 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
GS100840117326576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JCXApparatus, Suction, Ward Use, Portable, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-08
Device Publish Date2023-12-29

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