TRACOE® twist plus

GUDID 04035324028009

Spare Inner Cannulas, with 15 mm Connector, 30 units

Tracoe medical GmbH

Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use
Primary Device ID04035324028009
NIH Device Record Key91f983f3-5ecc-498e-b82e-b2664e2ec33a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRACOE® twist plus
Version Model NumberREF 521-09-XXX
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
Phone+49613691690
Emailinfo@tracoe.com

Device Dimensions

Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Products must be stored in cool and dry location. Temporary storage for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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
GS104035324028009 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-23
Device Publish Date2023-06-15

On-Brand Devices [TRACOE® twist plus]

04035324028009Spare Inner Cannulas, with 15 mm Connector, 30 units
04035324027996Spare Inner Cannulas, with 15 mm Connector, 30 units
04035324027989Spare Inner Cannulas, with 15 mm Connector, 30 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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