TRACOE twist REF 303-10

GUDID 04035324034512

Tracheostomy Tube

Tracoe medical GmbH

Tracheostomy tube, non-reinforced, non-customized, single-use
Primary Device ID04035324034512
NIH Device Record Key89cb8b24-515e-40f4-9ed8-69280d50f255
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRACOE twist
Version Model NumberREF 303-10
Catalog NumberREF 303-10
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 Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter

Operating and Storage Conditions

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
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
GS104035324034512 [Primary]

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]

04035324063710Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324063512Tracheostomy Tube, Fenestrated
04035324063413Tracheostomy Tube
04035324063314Tracheostomy Tube, Fenestrated, with Low Pressure Cuff
04035324063215Tracheostomy Tube with Low Pressure Cuff
04035324058716Spare Inner Cannulas, Fenestrated, with 15 mm Connector (light blue), 3 units
04035324058518Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324041510Spare Inner Cannulas, Fenestrated, with 15 mm Connector (light blue), 3 units
04035324041411Spare Inner Cannulas, Fenestrated, with 15 mm Connector (light blue), 3 units
04035324041312Spare Inner Cannulas, Fenestrated, with 15 mm Connector (light blue), 3 units
04035324041213Spare Inner Cannulas, Fenestrated, with 15 mm Connector (light blue), 3 units
04035324041114Spare Inner Cannulas, Fenestrated, with 15 mm Connector (light blue), 3 units
04035324041015Spare Inner Cannulas, Fenestrated, with 15 mm Connector (light blue), 3 units
04035324038510Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324038411Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324038312Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324038213Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324038114Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324038015Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324036417Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324036318Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324036219Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324036110Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324036011Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324035915Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line
04035324035212Tracheostomy Tube, Fenestrated
04035324035113Tracheostomy Tube, Fenestrated
04035324035014Tracheostomy Tube, Fenestrated
04035324034918Tracheostomy Tube, Fenestrated
04035324034819Tracheostomy Tube, Fenestrated
04035324034710Tracheostomy Tube, Fenestrated
04035324034512Tracheostomy Tube
04035324034413Tracheostomy Tube
04035324034314Tracheostomy Tube
04035324034215Tracheostomy Tube
04035324034116Tracheostomy Tube
04035324034017Tracheostomy Tube
04035324033812Tracheostomy Tube, Fenestrated, with Low Pressure Cuff
04035324033713Tracheostomy Tube, Fenestrated, with Low Pressure Cuff
04035324033614Tracheostomy Tube, Fenestrated, with Low Pressure Cuff
04035324033515Tracheostomy Tube, Fenestrated, with Low Pressure Cuff
04035324033416Tracheostomy Tube, Fenestrated, with Low Pressure Cuff
04035324033317Tracheostomy Tube, Fenestrated, with Low Pressure Cuff
04035324033119Tracheostomy Tube with Low Pressure Cuff
04035324033010Tracheostomy Tube with Low Pressure Cuff
04035324032914Tracheostomy Tube with Low Pressure Cuff
04035324032815Tracheostomy Tube with Low Pressure Cuff
04035324032716Tracheostomy Tube with Low Pressure Cuff
04035324032617Tracheostomy Tube with Low Pressure Cuff
04035324018871Tracheostomy Tube, Fenestrated, with Low Pressure Cuff and Subglottic Suction Line
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.