FDA UDI
In Commercial Distribution
🇺🇸 United States
I.S.E. REF
DI: 05055273210552
·
Model: D200-0017
·
RANDOX LABORATORIES LIMITED
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- I.S.E. REF
- Primary DI
- 05055273210552
- Version / Model
- D200-0017
- Catalog Number
- D200-0017
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2f11f62c-7f30-4fd5-a1f3-caa7ca5a901c
Device Description
Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59241 | Reference electrode IVD | An electrochemical sensor intended to be used as a known reference for electrical potential in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273210552 | GS1 |
Customer Contacts
- Phone
- +44289445170
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024014 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius