GL GoodLife Glucose Control Solution(Level 1)

Basic Information

• Brand Name: GL GoodLife Glucose Control Solution(Level 1)
• Primary DI: 00389154000440
• Version / Model: GL GCS
• Catalog Number: 3C-01-810032
• Company Name: HMD BIOMEDICAL INC.
• Labeler DUNS: 658644174
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-30
• Public Version: 4
• Public Version Date: 2018-12-28
• Public Version Status: Update
• Public Device Record Key: dff656fb-df0c-4680-947c-bbec3b07d429
• Distribution End Date: 2018-12-28

Device Description

GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glucose System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00389154000716	GS1	box	650	Not in Commercial Distribution	2018-12-28
Primary	00389154000440	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120064	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 86 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius