GL GoodLife Blood Glucose Test Strip AC (50ct in foil)

Basic Information

• Brand Name: GL GoodLife Blood Glucose Test Strip AC (50ct in foil)
• Primary DI: 00389154000075
• Version / Model: AC11-Foil
• Catalog Number: 3K-01-16003C
• Company Name: HMD BIOMEDICAL INC.
• Labeler DUNS: 658644174
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 120225fd-044a-4df5-86dc-dce5d42d0ab3
• Distribution End Date: 2017-03-13

Device Description

GoodLife AC Blood Glucose Test Strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	862.1345	2
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00389154000075	GS1
Package	00389154000556	GS1	Foil	100	Not in Commercial Distribution	2017-03-13

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K113307	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius