AccessGUDID - DEVICE: MEIBOMIAN GLAND EVALUATOR (00859623006919)

GUDID

Device Identifier (DI) Information

Brand Name: MEIBOMIAN GLAND EVALUATOR
Version or Model: DMI-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400000
Company Name: TEARSCIENCE, INC.

Primary DI Number: 00859623006919
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791626901 *Terms of Use

Device Description: ASSEMBLY PKGD LIPISCAN - US

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?
62592	Meibomian gland camera	A mains electricity (AC-powered) optical device intended for infrared (IR) image capture of the meibomian glands for evaluation of structural abnormalities of the meibomian glands. It includes patient head/chin supports, an IR source(s), IR camera, controls and appropriate software intended to enable analysis of the images; it may include an eyelid everter to assist imaging of the meibomian glands.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKI	Camera, ophthalmic, ac-powered

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e51828f8-7e00-4277-9738-a6ba2031a567
Public Version Date: October 04, 2019
Public Version Number: 5
DI Record Publish Date: September 23, 2016