DEVICE: Precision Xtra (00093815997283)

Device Identifier (DI) Information

Precision Xtra
99728
In Commercial Distribution
99728
ABBOTT DIABETES CARE INC
00093815997283
GS1

50
966390890 *Terms of Use
Precision Xtra Blood Glucose Test Strips
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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/ketone 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 together for the quantitative measurement of glucose and ketones 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.
Glucose/ketone monitoring system IVD, point-of-care A collection of devices including a portable, battery-powered, semi-automated or automated instrument (meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose and ketones in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
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FDA Product Code

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Product Code Product Code Name
NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
LFR Glucose dehydrogenase, glucose
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K051213 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 Temperature: between 39 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

26da250a-1620-4f73-8c62-c8d7c96b041f
July 06, 2018
3
July 22, 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
40093815997281 12 00093815997283 In Commercial Distribution Case
30093815997284 12 00093815997283 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
NDC/NHRIC 57599-9728-4
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Unit of Use DI

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Unit of Use DI Number: 10093815997280 CLOSE

Direct Marking (DM)

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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)527-3339
xx@xx.xx
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