FDA UDI
In Commercial Distribution
🇺🇸 United States
Na/K/Cl/Li Analyzer
DI: 00386100002909
·
Model: 2021
·
MEDICA CORPORATION
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Na/K/Cl/Li Analyzer
- Primary DI
- 00386100002909
- Version / Model
- 2021
- Catalog Number
- 2021
- Company Name
- MEDICA CORPORATION
- Labeler DUNS
- 112942404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-04
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 776339a7-5a22-4b6c-af9a-30be9755775c
Device Description
EasyLyte Na/K/Cl/Li Analyzer
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JIH | Flame Photometry, Lithium | Clinical Toxicology | 862.3560 | 2 |
| CEM | Electrode, Ion Specific, Potassium | Clinical Chemistry | 862.1600 | 2 |
| JGS | Electrode, Ion Specific, Sodium | Clinical Chemistry | 862.1665 | 2 |
| CGZ | Electrode, Ion-Specific, Chloride | Clinical Chemistry | 862.1170 | 2 |
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 | 00386100002909 | GS1 |
Customer Contacts
- Phone
- 781-275-4892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963763 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius