Resp-O2 Endotracheal Tube with Stylette, Uncuffed, 4.0 mm

GUDID 00840117317420

DYNAREX CORPORATION

Basic endotracheal tube, single-use
Primary Device ID00840117317420
NIH Device Record Key694987e2-45a0-47cf-a335-0cb762d6e58c
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Endotracheal Tube with Stylette, Uncuffed, 4.0 mm
Version Model Number36231
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
GS100840117312845 [Package]
Package: Box [10 Units]
In Commercial Distribution
GS100840117312852 [Package]
Contains: 00840117312845
Package: Case [10 Units]
In Commercial Distribution
GS100840117317420 [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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