FDA UDI
In Commercial Distribution
🇺🇸 United States
MediSense
DI: 00093815801399
·
Model: 80139
·
ABBOTT DIABETES CARE INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MediSense
- Primary DI
- 00093815801399
- Version / Model
- 80139
- Catalog Number
- 80139
- Company Name
- ABBOTT DIABETES CARE INC
- Labeler DUNS
- 966390890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-28
- Public Version
- 3
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- a9d0bb39-d800-46a2-a14e-01cb34e1a425
Device Description
MediSense Glucose & Ketone Control Solutions
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 |
|---|---|---|---|---|
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60093815801391 | GS1 | Case | 240 | In Commercial Distribution | |
| Primary | 00093815801399 | GS1 | ||||
| Secondary | 57599-0139-1 | NDC/NHRIC |
Customer Contacts
- Phone
- +1(888)522-5226
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 86 Degrees Fahrenheit