AccessGUDID - DEVICE: MyGlucoHealth® BT Meter (00852668007095)

GUDID

Device Identifier (DI) Information

Brand Name: MyGlucoHealth® BT Meter
Version or Model: MGH-BT1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ENTRA HEALTH SYSTEMS LLC

Primary DI Number: 00852668007095
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 826314044 *Terms of Use

Device Description: Blood Glucose meter (label)

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):	Yes
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?
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081703	000

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 50 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.3 Microliter

Device Record Status

Public Device Record Key: 5069332c-b8da-4717-9816-915de6055cd6
Public Version Date: October 28, 2021
Public Version Number: 6
DI Record Publish Date: January 27, 2017