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© 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 |
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
October 18, 2023
7
July 22, 2016
October 18, 2023
7
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