Resp-O2 Endotracheal Tube with Styette, Uncuffed, 3.5mm

GUDID 00840117317413

DYNAREX CORPORATION

Basic endotracheal tube, single-use
Primary Device ID00840117317413
NIH Device Record Key7318d5d4-c4b8-44c0-a0f4-4d494a9d7f55
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Endotracheal Tube with Styette, Uncuffed, 3.5mm
Version Model Number36230
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
GS100840117312821 [Package]
Package: Box [10 Units]
In Commercial Distribution
GS100840117312838 [Package]
Contains: 00840117312821
Package: Case [10 Units]
In Commercial Distribution
GS100840117317413 [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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