DEVICE: FreeStyle Precision Pro (00093815712848)

Device Identifier (DI) Information

FreeStyle Precision Pro
71284
In Commercial Distribution
71284
ABBOTT DIABETES CARE INC
00093815712848
GS1

100
966390890 *Terms of Use
FreeStyle Precision Pro 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?
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
JQP CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
LFR Glucose dehydrogenase, glucose
JIN NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K132511 000
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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
Special Storage Condition, Specify: N/A
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Clinically Relevant Size

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

0d03798c-c0a4-4bc8-9364-75f5f7ff52a0
December 11, 2019
8
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
30093815712849 6 00093815712848 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
NDC/NHRIC 57599-1284-5
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Unit of Use DI

[?]
Unit of Use DI Number: 10093815712845 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(877)529-7185
xx@xx.xx
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