GL GoodLife Blood Glucose Meter AC-11 3K-01-16003S

GUDID 00389154000686

GL GoodLife Blood Glucose Meter (single patient home use)

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, home-use
Primary Device ID00389154000686
NIH Device Record Key66437950-86e9-4b7f-8c38-1f19dbfe77f8
Commercial Distribution Discontinuation2017-01-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGL GoodLife Blood Glucose Meter AC-11
Version Model Number3K-01-16003S
Catalog Number3K-01-16003S
Company DUNS658644174
Company NameHMD BIOMEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-555-3453
Emailsales@gl-diabetes.com
Phone1-800-555-3453
Emailsales@gl-diabetes.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100389154000679 [Primary]
GS100389154000686 [Package]
Contains: 00389154000679
Package: [60 Units]
Discontinued: 2017-01-25
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-25

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