AccessGUDID - DEVICE: Auto Lensmeter (08800074500251)

GUDID

Device Identifier (DI) Information

Brand Name: Auto Lensmeter
Version or Model: ALM-1P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ALM-1P
Company Name: VIEW-M TECHNOLOGY CO., LTD.

Primary DI Number: 08800074500251
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557821283 *Terms of Use

Device Description: This device aims to take the measurements of vertex powers, cylinder axis, prismatic power and prism base setting within a restricted area of unprocessed lens, processed framed lens and contact lens, Auto Lensmeter also has functions to measure UV/BLUE transmission. As an external feature, the angle of the LCD can be changed. User is able to measure the PD and OH value with the horizontal and vertical ruler GUI after adjusting the extended LCD at the lowest angle.

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):	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?
12326	Manually-adjusted lensmeter, line-powered	A mains electricity (AC-powered) ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism through manual adjustments to the instrument performed by the operator. Alternating current provides power for illumination [e.g., with a light-emitting diode (LED)] to make the measurements which are read directly through the optics.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLM	Instrument, Measuring, Lens, Ac-Powered

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 80 and 106 KiloPascal
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 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 -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f842d712-01b5-4754-904e-de2f344406dc
Public Version Date: January 18, 2023
Public Version Number: 1
DI Record Publish Date: January 10, 2023