AccessGUDID - DEVICE: VISERA TRACHEAL INTUBATION VIDEOSCOPE (04953170340246)

GUDID

Device Identifier (DI) Information

Brand Name: VISERA TRACHEAL INTUBATION VIDEOSCOPE
Version or Model: OLYMPUS LF TYPE V
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N4500330
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170340246
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: LF-V TRACHEAL INTUBATION VIDEO SCOPE

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:	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?
44962	Flexible video intubation laryngoscope, reusable	An endoscope with a flexible inserted portion intended for the visual examination of the trachea, and to assist the entry and positioning of an airway tube, typically an endotracheal (ET) tube, to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is thin and long to facilitate endoscope entry and the intubation procedure. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It is typically used during difficult and non-difficult intubation procedures when maintaining an airway open. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOQ	BRONCHOSCOPE (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 [?]
Ethylene Oxide
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: ca4485ec-17b0-4869-b7a5-9b551288370f
Public Version Date: January 16, 2023
Public Version Number: 7
DI Record Publish Date: September 21, 2016