FDA UDI
In Commercial Distribution
🇺🇸 United States
CardioChek
DI: 10304040037727
·
Model: 5700415
·
HENRY SCHEIN, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- CardioChek
- Primary DI
- 10304040037727
- Version / Model
- 5700415
- Catalog Number
- 5700415
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-01-05
- Public Version
- 4
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- cac94b7c-5427-4d10-aa0c-9b17a6593e18
Device Description
Cardiochek eGLU Glucose Test
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52848 | Multiple lipid analyte IVD, kit, multiple technologies | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to produce a lipid profile, using a number of different technologies on a single analyser. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10304040037727 | GS1 | ||||
| Unit of Use | 00304040037720 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140068 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry.
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius