TRACOE mini REF 355-4.0-C65

GUDID 04035324016006

Tracheostomy Tube for Children

Tracoe medical GmbH

Tracheostomy tube, non-reinforced, non-customized, single-use
Primary Device ID04035324016006
NIH Device Record Keyd33cd767-b7d3-4c8a-bc9d-9decba057107
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRACOE mini
Version Model NumberREF 355-4.0-C65
Catalog NumberREF 355-4.0-C65
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 Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.

Device Identifiers

Device Issuing AgencyDevice ID
GS104035324016006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, tracheostomy (w/wo connector)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2024-11-29
Device Publish Date2015-10-18

On-Brand Devices [TRACOE mini]

04035324016853Tracheostomy Tube for Children
04035324016846Tracheostomy Tube for Children
04035324016839Tracheostomy Tube for Children
04035324016303Tracheostomy Tube for Children
04035324016297Tracheostomy Tube for Children
04035324016280Tracheostomy Tube for Children
04035324016273Tracheostomy Tube for Children
04035324016266Tracheostomy Tube for Children
04035324016259Tracheostomy Tube for Children
04035324016242Tracheostomy Tube for Children
04035324016235Tracheostomy Tube for Children
04035324016228Tracheostomy Tube for Children
04035324016204Tracheostomy Tube for Children
04035324016198Tracheostomy Tube for Children
04035324016181Tracheostomy Tube for Children
04035324016174Tracheostomy Tube for Children
04035324016167Tracheostomy Tube for Children
04035324016150Tracheostomy Tube for Children
04035324016143Tracheostomy Tube for Children
04035324016136Tracheostomy Tube for Children
04035324016129Tracheostomy Tube for Children
04035324016105Tracheostomy Tube for Children
04035324016099Tracheostomy Tube for Children
04035324016082Tracheostomy Tube for Children
04035324016075Tracheostomy Tube for Children
04035324016068Tracheostomy Tube for Children
04035324016051Tracheostomy Tube for Children
04035324016044Tracheostomy Tube for Children
04035324016037Tracheostomy Tube for Children
04035324016020Tracheostomy Tube for Children
04035324016006Tracheostomy Tube for Children
04035324015993Tracheostomy Tube for Children
04035324015986Tracheostomy Tube for Children
04035324015979Tracheostomy Tube for Children
04035324015962Tracheostomy Tube for Children
04035324015955Tracheostomy Tube for Children
04035324015948Tracheostomy Tube for Children
04035324015931Tracheostomy Tube for Children
04035324015924Tracheostomy Tube for Children
04035324015917Tracheostomy Tube for Children
04035324015900Tracheostomy Tube for Children
04035324015894Tracheostomy Tube for Children
04035324015887Tracheostomy Tube for Children
04035324015870Tracheostomy Tube for Children
04035324015863Tracheostomy Tube for Children
04035324015856Tracheostomy Tube for Children
04035324015849Tracheostomy Tube for Children
04035324015832Tracheostomy Tube for Children
04035324015825Tracheostomy Tube for Children
04035324015801Tracheostomy Tube for Children
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.