AccessGUDID - DEVICE: Forsure (00815123011310)

GUDID

Device Identifier (DI) Information

Brand Name: Forsure
Version or Model: 11100020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11100020
Company Name: FORSURE MEDICAL PRODUCTS LLC

Primary DI Number: 00815123011310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033809722 *Terms of Use

Device Description: A sterile 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 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 to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

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":	No
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
BTO	Tube, Tracheostomy (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042684	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: STORE IN DRY CONDITIONS AWAY FROM HEAT AND LIGHT

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: UNCUFFED
Lumen/Inner Diameter: 2.0 Millimeter

Device Record Status

Public Device Record Key: 493766d8-7189-471a-b7b8-8f678fda43c7
Public Version Date: June 05, 2020
Public Version Number: 4
DI Record Publish Date: November 14, 2017