Resp-O2 CPAP Tubing 8' ( 2.4 m )

GUDID 00840117334311

DYNAREX CORPORATION

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Primary Device ID00840117334311
NIH Device Record Key7c6164e0-430b-4f7a-8594-702bd8b561f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 CPAP Tubing 8' ( 2.4 m )
Version Model Number39124
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117334304 [Package]
Package: Case [50 Units]
In Commercial Distribution
GS100840117334311 [Primary]

FDA Product Code

BZOSet, Tubing And Support, Ventilator (W Harness)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-25
Device Publish Date2024-03-15