FDA UDI
In Commercial Distribution
🇺🇸 United States
Clinical Refractometers Reichert® Digital Clinic-Chek
DI: 00812559011518
·
Model: 13940021
·
REICHERT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Clinical Refractometers Reichert® Digital Clinic-Chek
- Primary DI
- 00812559011518
- Version / Model
- 13940021
- Company Name
- REICHERT, INC.
- Labeler DUNS
- 126650253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-12
- Public Version
- 1
- Public Version Date
- 2025-08-20
- Public Version Status
- New
- Public Device Record Key
- 7b66501b-8cf1-41df-9470-29c37823faa1
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JRE | Refractometer For Clinical Use | Clinical Chemistry | 862.2800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37034 | Clinical specimen refractometer | A hand-held, battery-powered instrument intended to be used in a clinical setting, typically bedside, to measure the refractive index of a fluid clinical specimen to assess the concentration of its solutes (e.g., sugar or alcohol concentration in a urine specimen). Measurements obtained by this device can be used in the diagnosis, monitoring, and treatment of certain conditions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812559011518 | GS1 |