TRACOE twist plus REF 521-07

GUDID 04035324018192

Spare Inner Cannulas, with 15 mm Connector, 3 units

Tracoe medical GmbH

Tracheostomy tube, non-reinforced, non-customized, single-use
Primary Device ID04035324018192
NIH Device Record Key4715c07d-6151-4feb-8356-7cf274e00c1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRACOE twist plus
Version Model NumberREF 521-07
Catalog NumberREF 521-07
Company DUNS319414785
Company NameTracoe medical GmbH
Device Count3
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 Diameter7 Millimeter
Lumen/Inner Diameter7 Millimeter
Lumen/Inner Diameter7 Millimeter
Lumen/Inner Diameter7 Millimeter
Lumen/Inner Diameter7 Millimeter
Lumen/Inner Diameter7 Millimeter
Lumen/Inner Diameter7 Millimeter
Lumen/Inner Diameter7 Millimeter
Lumen/Inner Diameter7 Millimeter
Lumen/Inner Diameter7 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.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
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.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
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.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
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.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
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.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
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.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
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.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
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.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
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.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
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.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104035324018192 [Primary]
GS105701780328180 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOHTube tracheostomy and tube cuff

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 twist plus]

04035324019106TRACOE twist plus Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324019090TRACOE twist plus Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324019083TRACOE twist plus Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324019076TRACOE twist plus Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324018932TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
04035324018925TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
04035324018901TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
04035324018895TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic S
04035324018352Spare Inner Cannulas, with 15 mm Connector, 10 units
04035324018345Spare Inner Cannulas, with 15 mm Connector, 10 units
04035324018338Spare Inner Cannulas, with 15 mm Connector, 10 units
04035324018321Spare Inner Cannulas, with 15 mm Connector, 10 units
04035324018307Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324018291Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324018284Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324018277Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324018260Spare Inner Cannulas, with 15 mm Connector, 10 units
04035324018253Spare Inner Cannulas, with 15 mm Connector, 10 units
04035324018246Spare Inner Cannulas, with 15 mm Connector, 10 units
04035324018239Spare Inner Cannulas, with 15 mm Connector, 10 units
04035324018222Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324018215Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324018208Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324018192Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324018185TRACOE twist plus Tracheostomy Tube, Double Fenestrated
04035324018178TRACOE twist plus Tracheostomy Tube, Double Fenestrated
04035324018161TRACOE twist plus Tracheostomy Tube, Double Fenestrated
04035324018154TRACOE twist plus Tracheostomy Tube, Double Fenestrated
04035324018147TRACOE twist plus Tracheostomy Tube
04035324018130TRACOE twist plus Tracheostomy Tube
04035324018123TRACOE twist plus Tracheostomy Tube
04035324018109TRACOE twist plus Tracheostomy Tube
04035324018024TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff
04035324018000TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff
04035324017997TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff
04035324017980TRACOE twist plus Tracheostomy Tube, Double Fenestrated with Low Pressure Cuff
04035324017973TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff
04035324017966TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff
04035324017959TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff
04035324017942TRACOE twist plus Tracheostomy Tube with Low Pressure Cuff

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