AccessGUDID - DEVICE: NAR Tracheostomy Kit (00842209107315)

GUDID

Device Identifier (DI) Information

Brand Name: NAR Tracheostomy Kit
Version or Model: 10-0048
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10-0048
Company Name: NORTH AMERICAN RESCUE, LLC

Primary DI Number: 00842209107315
Issuing Agency: GS1
Commercial Distribution End Date: March 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 832426782 *Terms of Use

Device Description: TRACHEAL TUBE - CUFFED 6.0mm ID w' BOUGIE

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:	Yes
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
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Outer Diameter: 8.0 Millimeter

Device Record Status

Public Device Record Key: 344faaad-9b8e-49db-97a6-c1893ad85015
Public Version Date: March 17, 2022
Public Version Number: 3
DI Record Publish Date: September 17, 2018