AccessGUDID - DEVICE: GL GoodLife Blood Glucose Test Strip AC (50ct in foil) (00389154000075)

GUDID

Device Identifier (DI) Information

Brand Name: GL GoodLife Blood Glucose Test Strip AC (50ct in foil)
Version or Model: AC11-Foil
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3K-01-16003C
Company Name: HMD BIOMEDICAL INC.

Primary DI Number: 00389154000075
Issuing Agency: GS1
Commercial Distribution End Date: March 13, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 658644174 *Terms of Use

Device Description: GoodLife AC Blood Glucose Test Strips

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?
47655	Home-use/point-of-care blood glucose/blood pressure monitoring system	A collection of devices designed to semi-quantitatively measure glucose in a specimen of whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. The device is normally available [non-prescription] over-the-counter (OTC) for home-use, but may also be used in a clinical setting for multi-patient monitoring of blood glucose and blood pressure.	Obsolete	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 Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 120225fd-044a-4df5-86dc-dce5d42d0ab3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 08, 2016