DEVICE: ReliOn® Prime Blood Glucose Test Strips (00605388022943)
Device Identifier (DI) Information
ReliOn® Prime Blood Glucose Test Strips
700050 / 700100
In Commercial Distribution
WAL-MART STORES, INC.
700050 / 700100
In Commercial Distribution
WAL-MART STORES, INC.
Blood Glucose Test Strips
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62537 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CGA | GLUCOSE OXIDASE, GLUCOSE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K091102 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 39 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0e76da1c-5403-4e01-8200-f9c8d5036c20
July 06, 2018
3
February 17, 2017
July 06, 2018
3
February 17, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10605388022940 | 12 | 00605388022943 | In Commercial Distribution | Case Pack | |
00681131078221 | 2 | 00605388022943 | Carton | ||
10681131078228 | 6 | 00681131078221 | Case Pack |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
50605388022948
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)776-0662
xxx@xxx.xxx
xxx@xxx.xxx