FDA UDI
In Commercial Distribution
🇺🇸 United States
FreeStyle
DI: 00699073704320
·
Model: 70432
·
ABBOTT DIABETES CARE INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FreeStyle
- Primary DI
- 00699073704320
- Version / Model
- 70432
- Catalog Number
- 70432
- Company Name
- ABBOTT DIABETES CARE INC
- Labeler DUNS
- 966390890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-13
- Public Version
- 1
- Public Version Date
- 2018-05-14
- Public Version Status
- New
- Public Device Record Key
- ba2f25f3-58bf-43ef-83a9-72f8513b0ef8
Device Description
FreeStyle Control Solution
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (specified) analyte controls (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62537 | Glucose monitoring system IVD, home-use | A collection of devices including a portable, battery-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 for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20699073704324 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00699073704320 | GS1 |
Customer Contacts
- Phone
- +1(888)522-5226
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 35 – 86 Degrees Fahrenheit