DEVICE: Precision Xtra (00093815707455)
Device Identifier (DI) Information
Precision Xtra
70745
In Commercial Distribution
70745
ABBOTT DIABETES CARE INC
70745
In Commercial Distribution
70745
ABBOTT DIABETES CARE INC
Precision Xtra Blood ß-Ketone 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? |
|---|---|---|---|---|
| 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 |
| 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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| JIN | NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K060768 | 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
76122044-9b90-4fe0-a2fd-bb680e8aa5f9
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 |
|---|---|---|---|---|---|
| 30093815707456 | 12 | 00093815707455 | In Commercial Distribution | Case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| NDC/NHRIC | 57599-0745-1 |
Unit of Use DI
[?]
Unit of Use DI Number:
10093815707452
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)527-3339
xx@xx.xx
xx@xx.xx