TRACOE comfort REF 101-06

GUDID 04035324000418

Tube without Inner Cannula

Tracoe medical GmbH

Tracheostomy tube, non-reinforced, non-customized, reusable
Primary Device ID04035324000418
NIH Device Record Key5c1a3911-0ba3-4ded-b2de-7bddde8b6054
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRACOE comfort
Version Model NumberREF 101-06
Catalog NumberREF 101-06
Company DUNS319414785
Company NameTracoe medical GmbH
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49613691690
Emailinfo@tracoe.com
Phone+49613691690
Emailinfo@tracoe.com
Phone+49613691690
Emailinfo@tracoe.com
Phone+49613691690
Emailinfo@tracoe.com
Phone+49613691690
Emailinfo@tracoe.com
Phone+49613691690
Emailinfo@tracoe.com
Phone+49613691690
Emailinfo@tracoe.com
Phone+49613691690
Emailinfo@tracoe.com
Phone+49613691690
Emailinfo@tracoe.com
Phone+49613691690
Emailinfo@tracoe.com

Device Dimensions

Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not resterilize.

Device Identifiers

Device Issuing AgencyDevice ID
GS104035324000418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, tracheostomy (w/wo connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2024-11-29
Device Publish Date2017-07-01

On-Brand Devices [TRACOE comfort]

04035324031511Extra-Long Tube with 15 mm Connector, clamp below
04035324031412Extra-Long Tube with 15 mm Connector, clamp at the top
04035324031115Extra-Long Tube with 15 mm Connector, clamp below
04035324031016Extra-Long Tube with 15 mm Connector, clamp at the top
04035324030712Extra-Long Tube with 15 mm Connector, clamp below
04035324030613Extra-Long Tube with 15 mm Connector, clamp at the top
04035324030316Extra-Long Tube with 15 mm Connector, clamp below
04035324030217Extra-Long Tube with 15 mm Connector, clamp at the top
04035324029914Extra-Long Tube with 15 mm Connector, clamp below
04035324029815Extra-Long Tube with 15 mm Connector, clamp at the top
04035324029518Extra-Long Tube with 15 mm Connector, clamp below
04035324029419Extra-Long Tube with 15 mm Connector, clamp at the top
04035324029112Extra-Long Tube with 15 mm Connector, clamp below
04035324029013Extra-Long Tube with 15 mm Connector, clamp at the top
04035324028719Extra-Long Tube with 15 mm Connector, clamp below
04035324028610Extra-Long Tube with 15 mm Connector, clamp at the top
04035324027910Extra-Long Tube, with Swivel Speaking Valve, Type B
04035324027811Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula
04035324027712Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B
04035324027644Tube, with Slide-On Speaking Valve, Type A and additional Inner cannula with 15 mm Connector
04035324027637Tube, with Slide-On Speaking Valve, Type A and additional Inner cannula with 15 mm Connector
04035324027613Extra-Long Tube, with Swivel Speaking Valve, Type B
04035324027514Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula
04035324027446Tube with 15 mm Connector and second additional inner cannula, clamp below
04035324027439Tube with 15 mm Connector and second additional inner cannula, clamp below
04035324027422Tube with 15 mm Connector and second additional inner cannula, clamp below
04035324027415Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B
04035324027408Tube with 15 mm Connector and second additional inner cannula, clamp below
04035324027392Tube with 15 mm Connector and second additional inner cannula, clamp below
04035324027385Tube with 15 mm Connector and second additional inner cannula, clamp below
04035324027378Tube with 15 mm Connector and second additional inner cannula, clamp below
04035324027361Tube with 15 mm Connector and second additional inner cannula, clamp below
04035324027316Extra-Long Tube, with Swivel Speaking Valve, Type B
04035324027309Tube, with Slide-On Speaking Valve, Type A and additional Inner cannula with 15 mm Connector
04035324027293Tube, with Slide-On Speaking Valve, Type A and additional Inner cannula with 15 mm Connector
04035324027286Tube, with Slide-On Speaking Valve, Type A and additional Inner cannula with 15 mm Connector
04035324027279Tube, with Slide-On Speaking Valve, Type A and additional Inner cannula with 15 mm Connector
04035324027262Tube, with Slide-On Speaking Valve, Type A and additional Inner cannula with 15 mm Connector
04035324027255Tube, with Slide-On Speaking Valve, Type A and additional Inner cannula with 15 mm Connector
04035324027217Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Co
04035324027118Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula
04035324027019Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B
04035324026999Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp belo
04035324026982Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp belo
04035324026975Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp belo
04035324026968Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp belo
04035324026951Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp belo
04035324026944Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp belo
04035324026937Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp belo
04035324026920Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp belo

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