FDA UDI
In Commercial Distribution
🇺🇸 United States
Equate Blood Glucose Test Strips
DI: 00681131104869
·
Model: 038600
·
Unistrip Technologies, LLC
Product Codes
2
GMDN Terms
1
Identifiers
6
Pkg Device Count
50
Basic Information
- Brand Name
- Equate Blood Glucose Test Strips
- Primary DI
- 00681131104869
- Version / Model
- 038600
- Catalog Number
- 038600
- Company Name
- Unistrip Technologies, LLC
- Labeler DUNS
- 043251054
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2023-09-27
- Public Version Status
- Update
- Public Device Record Key
- 215d2f11-b06a-4575-bb52-706f97cd61a8
Device Description
Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.
Device Characteristics
- Single Use
- No
- 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 |
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53303 | Glucose IVD, kit, electrometry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00681131304863 | GS1 | Corrugated Carton | 24 | Not in Commercial Distribution | 2020-02-05 |
| Primary | 00681131104869 | GS1 | ||||
| Unit of Use | 90681131104862 | GS1 | ||||
| Package | 30681131104860 | GS1 | Vial | 1 | In Commercial Distribution | |
| Package | 10681131104866 | GS1 | Corrugated Carton | 24 | In Commercial Distribution | |
| Secondary | 49035-0386-00 | NDC/NHRIC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.