FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Precision Xtra
DI: 00093815715023
·
Model: 71502
·
ABBOTT DIABETES CARE INC
Product Codes
3
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Precision Xtra
- Primary DI
- 00093815715023
- Version / Model
- 71502
- Catalog Number
- 71502
- Company Name
- ABBOTT DIABETES CARE INC
- Labeler DUNS
- 966390890
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-12
- Public Version
- 8
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 59ed128b-7c30-4e23-9d48-3d45b6bbe957
- Distribution End Date
- 2023-04-20
Device Description
Precision Xtra Blood Glucose & Ketone Monitoring System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Clinical Chemistry | 862.1345 | 2 |
| JIN | NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1435 | 1 |
| LFR | Glucose dehydrogenase, glucose | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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 | 30093815715024 | GS1 | Case | 4 | Not in Commercial Distribution | 2023-04-20 |
| Primary | 00093815715023 | GS1 | ||||
| Secondary | 57599-1502-1 | NDC/NHRIC |
Customer Contacts
- Phone
- +1(800)527-3339
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040814 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 86 Degrees Fahrenheit