FDA UDI
In Commercial Distribution
🇺🇸 United States
Clever Choice
DI: 00898302139425
·
Model: HD Strips Non-Retail
·
SIMPLE DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Clever Choice
- Primary DI
- 00898302139425
- Version / Model
- HD Strips Non-Retail
- Catalog Number
- 98302-1391-42
- Company Name
- SIMPLE DIAGNOSTICS INC
- Labeler DUNS
- 004135503
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-08-12
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 21397f15-580d-47d2-bd12-a7bbb2a2e774
Device Description
Non-Retail Blood Glucose Test Strips for Clever Choice HD and Voice HD Blood Glucose Meters.
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 |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30854 | Home-use/point-of-care blood glucose monitoring system IVD | 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 together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10898302139422 | GS1 | Case | 400 | In Commercial Distribution | |
| Primary | 00898302139425 | GS1 | ||||
| Unit of Use | 20898302139429 | GS1 |
Customer Contacts
- Phone
- 1.877.342.2385
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 104 Degrees Fahrenheit