DEVICE: Pharmacist's Choice (00862850000223)

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Device Identifier (DI) Information

Pharmacist's Choice
Test Strips - Retail
62850-0000-22
SIMPLE DIAGNOSTICS INC
00862850000223
GS1
50
Retail Blood Glucose Test Strips for Clever Choice HD and Voice HD Blood Glucose Meters.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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.
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FDA Product Code

[?]
Product Code Product Code Name
NBW System, Test, Blood Glucose, Over The Counter
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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 Temperature: between 39 and 104 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 12, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10862850000220 400 00862850000223 In Commercial Distribution Case
10862850000223 40 00862850000223 In Commercial Distribution Inner Case
20862850000223 10 10862850000223 In Commercial Distribution Outer Case
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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: 30862850000224 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1.877.342.2385
customerservice@simplediagnostics.com
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