FDA UDI
In Commercial Distribution
🇺🇸 United States
Daily Cleaning Solution Kit
DI: 00386100002398
·
Model: 2118
·
MEDICA CORPORATION
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Daily Cleaning Solution Kit
- Primary DI
- 00386100002398
- Version / Model
- 2118
- Catalog Number
- 2118
- 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
- 1
- Public Version Date
- 2019-01-04
- Public Version Status
- New
- Public Device Record Key
- 85af9be6-deef-48c5-90d5-2c57eaadf293
Device Description
Daily Cleaning Solution Kit for use with EasyStat, EasyBloodGas, EasyLyte and EasyElectrolyte Analyzers
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | Clinical Chemistry | 862.1600 | 2 |
| JGS | Electrode, Ion Specific, Sodium | Clinical Chemistry | 862.1665 | 2 |
| JFP | Electrode, Ion Specific, Calcium | Clinical Chemistry | 862.1145 | 2 |
| GKF | Instrument, Hematocrit, Automated | Hematology | 864.5600 | 2 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | Clinical Chemistry | 862.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59058 | Wash/cleaning solution IVD, automated/semi-automated system | A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00386100002398 | GS1 |
Customer Contacts
- Phone
- 781-275-4892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021515 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius