AccessGUDID - DEVICE: ALM800 (03615020000236)

GUDID

Device Identifier (DI) Information

Brand Name: ALM800
Version or Model: ALM800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ESSILOR INTERNATIONAL

Primary DI Number: 03615020000236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 277373213 *Terms of Use

Device Description: This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis. It also performs automatic discrimination of progressive lens, pupillary distance (PD) measurement of glass lens, UV cut percentage measurement, blue light which harmful to eyes cut percentage measurement, blue light transmittance measurement which necessary to adjust the circadian rhythm

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?
45753	Automated lensmeter	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. The device is fully automated and does not require manual adjustments of its measurement systems. It provides the operator with automatic readings on an integral screen, and will typically record and print-out the results.	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
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7dbcd85c-af82-4211-8c62-a6a0d70d4c5b
Public Version Date: October 11, 2023
Public Version Number: 1
DI Record Publish Date: October 03, 2023