TRACOE® twist

GUDID 04035324027835

Tracheostomy Tube, Fenestrated, with Low Pressure Cuff and optimated Subglottic Suction Line ( product variant)

Tracoe medical GmbH

Tracheostomy tube, non-reinforced, non-customized, single-use
Primary Device ID04035324027835
NIH Device Record Key102ac5a1-2511-401f-80ad-6831e17a0688
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRACOE® twist
Version Model NumberREF 888-306-08-S
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 Usetrue
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
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 Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter
Lumen/Inner Diameter8 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.

Device Identifiers

Device Issuing AgencyDevice ID
GS104035324027835 [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 Date2025-04-10
Device Publish Date2016-01-19

On-Brand Devices [TRACOE® twist]

04035324027972Spare Inner Cannulas, with 15 mm Connector, 30 units
04035324027965Spare Inner Cannulas, with 15 mm Connector, 30 units
04035324027958Spare Inner Cannulas, with 15 mm Connector, 30 units
04035324027866Spare Inner Cannulas, with 15 mm Connector, 30 units
04035324058617Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324058419Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units
04035324056910Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
04035324056811Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
04035324056712Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
04035324056514Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
04035324056415Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
04035324056316Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking
04035324049110Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units
04035324040513Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324040414Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324040216Spare Inner Cannulas, with 15 mm Connector, 3 units
04035324039517Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units
04035324039319Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units
04035324039111Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units
04035324038718Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units
04035324037315Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units
04035324037117Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units
04035324036912Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units
04035324035816Laryngectomy Tube
04035324035717Laryngectomy Tube
04035324035618Laryngectomy Tube
04035324035410Laryngectomy Tube
04035324027835Tracheostomy Tube, Fenestrated, with Low Pressure Cuff and optimated Subglottic Suction Line (
04035324016891Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line, with atraumatic insertion
04035324016877Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line, with atraumatic insertion
04035324015207Tracheostomy Tube, Fenestrated, with Low Pressure Cuff, with atraumatic insertion system
04035324015191Tracheostomy Tube, Fenestrated, with Low Pressure Cuff, with atraumatic insertion system
04035324015184Tracheostomy Tube, Fenestrated, with Low Pressure Cuff, with atraumatic insertion system
04035324015177Tracheostomy Tube with Low Pressure Cuff, with atraumatic insertion system
04035324015160Tracheostomy Tube with Low Pressure Cuff, with atraumatic insertion system
04035324015153Tracheostomy Tube with Low Pressure Cuff, with atraumatic insertion system
04035324011469Inner Cannulas, Fenestrated, with Integrated Speaking Valve (light blue), 2 units

Trademark Results [TRACOE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRACOE
TRACOE
75072311 2117376 Live/Registered
TRACOE MEDICAL GMBH
1996-03-12

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