Resp-O2 Endotracheal Tube Cuffed, 6.5 mm

GUDID 00840117313002

Sterile-Eo

Dynarex Corporation

Basic endotracheal tube, single-use
Primary Device ID00840117313002
NIH Device Record Key9db09c7a-0fef-4c7e-a644-476a62b4d7a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Endotracheal Tube Cuffed, 6.5 mm
Version Model Number36239
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117313002 [Package]
Contains: 00840117317505
Package: Box [10 Units]
In Commercial Distribution
GS100840117313019 [Package]
Package: Shipper [10 Units]
In Commercial Distribution
GS100840117317505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTRTube, Tracheal (W/Wo Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-01
Device Publish Date2024-10-24

Devices Manufactured by Dynarex Corporation

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00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm 2024-11-01 Sterile-EO
00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm 2024-11-01 Sterile-EO
00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm 2024-11-01 Sterile-EO
00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm 2024-11-01 Sterile-Eo
00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm 2024-11-01 Sterile-Eo
00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm2024-11-01Sterile-Eo
00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm2024-11-01 Sterile-Eo
00840117313026 - Resp-O2 Endotracheal Tube Cuffed, 7.0 mm 2024-11-01 Sterile-Eo

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