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

Device Identifier (DI) Information

GL GoodLife Blood Glucose Test Strip AC (50ct in foil)
AC11-Foil
Not in Commercial Distribution
3K-01-16003C
HMD BIOMEDICAL INC.
00389154000075
GS1
March 13, 2017
1
658644174 *Terms of Use
GoodLife AC Blood Glucose Test Strips
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K113307 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

120225fd-044a-4df5-86dc-dce5d42d0ab3
July 06, 2018
3
November 08, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00389154000556 100 00389154000075 2017-03-13 Not in Commercial Distribution Foil
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
1-855-692-3511
Sales@gl-diabetes.com
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