AccessGUDID - DEVICE: Shiley (10884521726321)

GUDID

Device Identifier (DI) Information

Brand Name: Shiley
Version or Model: 10CN10ER
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521726321
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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 [?]
K193077	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 79 Millimeter
Outer Diameter: 13.8 Millimeter
Angle: 90 degree
Device Size Text, specify: Cuff Resting Diameter, 28.6,MM;Inner Cannula Diamter,9.0,MM;Inner Diameter,10.0,MM;Proximal Length 3 (D),33,MM;Proximal Length 4 (E),55,MM

Device Record Status

Public Device Record Key: d6890391-dfea-4984-84c2-30dfa825297d
Public Version Date: June 13, 2025
Public Version Number: 5
DI Record Publish Date: June 11, 2020