DEVICE: Precision Xtra (00093815998778)
Device Identifier (DI) Information
Precision Xtra
99877
In Commercial Distribution
99877
ABBOTT DIABETES CARE INC
99877
In Commercial Distribution
99877
ABBOTT DIABETES CARE INC
Precision Xtra Blood Glucose Test Strips
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LFR | Glucose dehydrogenase, glucose |
NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K051213 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 39 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a30d5c47-7903-4671-95b0-fceb1e4bf472
July 06, 2018
3
July 22, 2016
July 06, 2018
3
July 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30093815998779 | 6 | 00093815998778 | In Commercial Distribution | Case | |
40093815998776 | 6 | 00093815998778 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
NDC/NHRIC | 57599-9877-5 |
Unit of Use DI
[?]
Unit of Use DI Number:
10093815998775
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)527-3339
xx@xx.xx
xx@xx.xx