AccessGUDID - DEVICE: Optima View Video Laryngoscope for Single Use Blades (05055382859840)

GUDID

Device Identifier (DI) Information

Brand Name: Optima View Video Laryngoscope for Single Use Blades
Version or Model: 4000.310.50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TIMESCO HEALTHCARE LIMITED

Primary DI Number: 05055382859840
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 896967197 *Terms of Use

Device Description: Optima View Video Laryngoscope Handle and LCD Display 3.75'' For Single Use Blades

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?
62761	Video intubation laryngoscope handle/monitor	A non-sterile component of a bladed video intubation laryngoscope intended to enable the positioning of the blade into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a monitor for the user to view anatomical images of the larynx/trachea transmitted by a video system from an electronic camera at the distal end of the blade. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCW	Laryngoscope, Rigid

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f871f61a-2318-42fb-8887-f229588b70b4
Public Version Date: December 29, 2022
Public Version Number: 1
DI Record Publish Date: December 21, 2022