TRACOE mini REF 355-4.0

GUDID 04035324011995

Tracheostomy Tube for Children

Tracoe medical GmbH

Tracheostomy tube, non-reinforced, non-customized, single-use
Primary Device ID04035324011995
NIH Device Record Key1c492ff6-573f-439c-b0d1-4787964d722e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRACOE mini
Version Model NumberREF 355-4.0
Catalog NumberREF 355-4.0
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
GS104035324011995 [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

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