Resp-O2 Endotracheal Tube With Stylette Cuffed, 7.0 mm

GUDID 00840117317628

DYNAREX CORPORATION

Basic endotracheal tube, single-use
Primary Device ID00840117317628
NIH Device Record Key3b49b939-94d8-4011-b1db-fbd490e7c2b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Endotracheal Tube With Stylette Cuffed, 7.0 mm
Version Model Number36251
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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100840117313248 [Package]
Package: Box [10 Units]
In Commercial Distribution
GS100840117313255 [Package]
Contains: 00840117313248
Package: Case [10 Units]
In Commercial Distribution
GS100840117317628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTRTube, Tracheal (W/Wo Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-23
Device Publish Date2022-05-15

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