DEVICE: Precision Xtra (00093815998372)

Device Identifier (DI) Information

Precision Xtra
99837
In Commercial Distribution
99837
ABBOTT DIABETES CARE INC
00093815998372
GS1

1
966390890 *Terms of Use
Precision Xtra Blood Glucose & Ketone Monitoring System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
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/ketone monitoring system IVD 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 testing, either at the point-of-care or in self-testing by a layperson, 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.
Home-use/point-of-care blood glucose monitoring system IVD 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 testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose 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
JIN NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K040814 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

59ab430c-514c-4622-a996-83b0d92e27ef
July 06, 2018
3
August 12, 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
30093815998373 4 00093815998372 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
NDC/NHRIC 57599-9837-1
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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
No
No CLOSE

Customer Contact

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+1(800)527-3339
support@abbottdiabetescare.com
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