AccessGUDID - DEVICE: Flexible Video Laryngoscope (NTSC) (00874485002671)

GUDID

Device Identifier (DI) Information

Brand Name: Flexible Video Laryngoscope (NTSC)
Version or Model: ENT-7000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 02-7201
Company Name: COGENTIX MEDICAL, INC.

Primary DI Number: 00874485002671
Issuing Agency: GS1
Commercial Distribution End Date: July 26, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 780024725 *Terms of Use

Device Description: No description.

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):	No
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?
35462	Flexible video laryngoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the larynx. It is inserted into the body through the mouth during laryngoscopy. Anatomical images are transmitted to the user by a video system at the distal end of the endoscope with the images showing on a monitor. This device is commonly used to evaluate or operate on laryngeal strictures, foreign bodies, or neoplasms; it is not intended for intubation of an artificial airway. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOB	Nasopharyngoscope (Flexible Or Rigid)

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c15eaee4-2373-49d0-95b4-32574ba7a4f2
Public Version Date: July 02, 2019
Public Version Number: 4
DI Record Publish Date: September 22, 2016