Standard Tracheal T-Tube

GUDID 00815347020860

Montgomery Tracheal T-Tube

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use Basic tracheostomy tube, single-use Basic tracheostomy tube, single-use
Primary Device ID00815347020860
NIH Device Record Key0cc06165-bc82-4091-afc7-ef9e2375b7d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Tracheal T-Tube
Version Model NumberST-512-S
Company DUNS076603380
Company NameHOOD, E BENSON LABORATORIES INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815347020860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, Tracheostomy (W/Wo Connector)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347020860]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347020860]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00815347020860]

Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-12-09

On-Brand Devices [Standard Tracheal T-Tube]

00815347020969Montgomery Tracheal T-Tube
00815347020952Montgomery Tracheal T-Tube
00815347020945Montgomery Tracheal T-Tube
00815347020938Montgomery Tracheal T-Tube
00815347020921Montgomery Tracheal T-Tube
00815347020914Montgomery Tracheal T-Tube
00815347020907Montgomery Tracheal T-Tube
00815347020891Montgomery Tracheal T-Tube
00815347020884Montgomery Tracheal T-Tube
00815347020877Montgomery Tracheal T-Tube
00815347020860Montgomery Tracheal T-Tube
00815347020211Montgomery Tracheal T-Tube
00815347020204Montgomery Tracheal T-Tube
00815347020198Montgomery Tracheal T-Tube
00815347020181Montgomery Tracheal T-Tube
00815347020174Montgomery Tracheal T-Tube
00815347020167Montgomery Tracheal T-Tube
00815347020150Montgomery Tracheal T-Tube
00815347020136Montgomery Tracheal T-Tube
00815347020037Montgomery Tracheal T-Tube

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.