DEVICE: GL GoodLife Blood Glucose Monitoring System (00389154000617)

Device Identifier (DI) Information

GL GoodLife Blood Glucose Monitoring System
AC-11 AC302
Not in Commercial Distribution
3K-01-16003N
HMD BIOMEDICAL INC.
00389154000617
GS1
December 09, 2016
1
658644174 *Terms of Use
Only GL GoodLife Blood Glucose Meter. No GCS in package, Economy type
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LFR Glucose Dehydrogenase, Glucose
NBW System, Test, Blood Glucose, Over The Counter
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K113307 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

8da337b4-92e9-47fd-b2da-0943d3f7104d
July 06, 2018
3
December 09, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00389154000624 60 00389154000617 2016-12-09 Not in Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE