FDA UDI
In Commercial Distribution
🇺🇸 United States
FreeStyle Precision Pro
DI: 00357599807009
·
Model: 72011-01
·
ABBOTT DIABETES CARE INC
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FreeStyle Precision Pro
- Primary DI
- 00357599807009
- Version / Model
- 72011-01
- Catalog Number
- 72011-01
- Company Name
- ABBOTT DIABETES CARE INC
- Labeler DUNS
- 966390890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-15
- Public Version
- 1
- Public Version Date
- 2020-04-23
- Public Version Status
- New
- Public Device Record Key
- f2cca906-4bd8-48cf-a15d-ef60d114ddd1
Device Description
FreeStyle Precision Pro Blood Glucose and ß-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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JQP | Calculator/data processing module, for clinical use | Clinical Chemistry | 862.2100 | 1 |
| NBW | System, test, blood glucose, over the counter | Clinical Chemistry | 862.1345 | 2 |
| LFR | Glucose dehydrogenase, glucose | Clinical Chemistry | 862.1345 | 2 |
| JIN | NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1435 | 1 |
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 |
|---|---|---|---|---|---|---|
| Direct Marking | 00357599815004 | GS1 | ||||
| Primary | 00357599807009 | 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
- -4 – 122 Degrees Fahrenheit