FDA UDI
In Commercial Distribution
🇺🇸 United States
ProLyte Electrolyte Analyzer
DI: 00811403019984
·
Model: 0-DD-PROLYTE
·
Diamond Diagnostics Inc.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ProLyte Electrolyte Analyzer
- Primary DI
- 00811403019984
- Version / Model
- 0-DD-PROLYTE
- Company Name
- Diamond Diagnostics Inc.
- Labeler DUNS
- 947514303
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-05
- Public Version
- 1
- Public Version Date
- 2023-06-13
- Public Version Status
- New
- Public Device Record Key
- f89d2e7b-435c-4aa0-b82a-f28241879475
Device Description
The Prolyte® Electrolyte Analyzer is intended to measure sodium, potassium, chloride and lithium in whole blood, serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases involving electrolyte imbalance.
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
- 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 |
|---|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | Clinical Chemistry | 862.1665 | 2 |
| CEM | Electrode, Ion Specific, Potassium | Clinical Chemistry | 862.1600 | 2 |
| CGZ | Electrode, Ion-Specific, Chloride | Clinical Chemistry | 862.1170 | 2 |
| JIH | Flame Photometry, Lithium | Clinical Toxicology | 862.3560 | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56682 | Ion-selective analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811403019984 | GS1 |