AccessGUDID - DEVICE: TRACOE twist plus (04035324028009)

GUDID

Device Identifier (DI) Information

Brand Name: TRACOE twist plus
Version or Model: REF 521-09-XXX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REF 521-09-XXX
Company Name: Tracoe medical GmbH

Primary DI Number: 04035324028009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 319414785 *Terms of Use

Device Description: Spare Inner Cannulas, with 15 mm Connector, 30 units

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35404	Tracheostomy tube, non-reinforced, non-customized, single-use	A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOH	Tube tracheostomy and tube cuff

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961449	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 9.0 Millimeter

Device Record Status

Public Device Record Key: 91f983f3-5ecc-498e-b82e-b2664e2ec33a
Public Version Date: November 25, 2024
Public Version Number: 4
DI Record Publish Date: June 15, 2023