FDA UDI
In Commercial Distribution
🇺🇸 United States
FreeStyle Precision Pro
DI: 00093815712886
·
Model: 71288
·
ABBOTT DIABETES CARE INC
Product Codes
4
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
Basic Information
- Brand Name
- FreeStyle Precision Pro
- Primary DI
- 00093815712886
- Version / Model
- 71288
- Catalog Number
- 71288
- Company Name
- ABBOTT DIABETES CARE INC
- Labeler DUNS
- 966390890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-08-12
- Public Version
- 7
- Public Version Date
- 2019-12-11
- Public Version Status
- Update
- Public Device Record Key
- 4478ff9c-b178-45bb-ab61-81f3ada15082
Device Description
FreeStyle Precision Pro Blood ß-Ketone Test Strips
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LFR | Glucose dehydrogenase, glucose | Clinical Chemistry | 862.1345 | 2 |
| JQP | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE | Clinical Chemistry | 862.2100 | 1 |
| JIN | NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1435 | 1 |
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30093815712887 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00093815712886 | GS1 | ||||
| Secondary | 57599-1288-4 | NDC/NHRIC | ||||
| Unit of Use | 10093815712883 | GS1 |
Customer Contacts
- Phone
- +1(877)529-7185
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132511 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 86 Degrees Fahrenheit