AccessGUDID - DEVICE: GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil) (00389154000204)

GUDID

Device Identifier (DI) Information

Brand Name: GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil)
Version or Model: 3L-10-16003A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3L-10-16003A
Company Name: HMD BIOMEDICAL INC.

Primary DI Number: 00389154000204
Issuing Agency: GS1
Commercial Distribution End Date: December 13, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 658644174 *Terms of Use

Device Description: GL GoodLife Blood Glucose Test Strip(Foil)

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:	Yes
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?
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	Active	false
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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)
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
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Humidity: between 50 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 06b04728-c9d6-4981-bc73-5f5a4fc2578c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 13, 2016