AccessGUDID - DEVICE: GL GoodLife Blood Glucose Monitoring System (00389154000617)

GUDID

Device Identifier (DI) Information

Brand Name: GL GoodLife Blood Glucose Monitoring System
Version or Model: AC-11 AC302
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3K-01-16003N
Company Name: HMD BIOMEDICAL INC.

Primary DI Number: 00389154000617
Issuing Agency: GS1
Commercial Distribution End Date: December 09, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 658644174 *Terms of Use

Device Description: Only GL GoodLife Blood Glucose Meter. No GCS in package, Economy type

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
LFR	Glucose Dehydrogenase, Glucose
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113307	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8da337b4-92e9-47fd-b2da-0943d3f7104d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 09, 2016