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© 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?
62643 Multiple clinical chemistry analyte monitoring system IVD, home-use
A collection of devices including a portable, electrically-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 multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended 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.
Active false
62644 Multiple clinical chemistry analyte monitoring system IVD, point-of-care
A collection of devices that includes one or more portable, electrically-powered instruments (meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used together exclusively at the point-of-care by medical professionals for the quantitative measurement of more than one clinical chemistry analyte [e.g., glucose, ketones, lipid(s), and/or creatinine] in a whole blood specimen. Some types may also include measurement of haemoglobin and/or haematocrit for rapid diagnosis of anaemia and/or blood loss.
Active false
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FDA Product Code

[?]
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
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 39 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

26da250a-1620-4f73-8c62-c8d7c96b041f
October 18, 2023
7
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

[?]
Unit of Use DI Number: 10093815997280 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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