| Primary Device ID | 00386100002909 |
| NIH Device Record Key | 776339a7-5a22-4b6c-af9a-30be9755775c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Na/K/Cl/Li Analyzer |
| Version Model Number | 2021 |
| Catalog Number | 2021 |
| Company DUNS | 112942404 |
| Company Name | MEDICA CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386100002909 [Primary] |
| JIH | Flame Photometry, Lithium |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-04 |
| Device Publish Date | 2018-12-04 |
| 00386100001735 - Urine Creatinine Calibrator Kit | 2019-03-11 Urine Creatinine Calibrator Kit for use with EasyRA Analyzer |
| 00386100001742 - Chemistry HDL Calibrator Kit | 2019-03-11 HDL Calibrator Kit for use with EasyRA Analyzer |
| 00386100001766 - Chemistry LDL Calibrator | 2019-03-11 LDL Calibrator for use with EasyRA Analyzer |
| 00386100001773 - Chemistry UALB Calibrator Kit | 2019-03-11 Microalbumin Calibrator Kit for use with EasyRA Analyzer |
| 00386100001797 - Chemistry HbA1c Calibrator Kit | 2019-03-11 HbA1c Calibrator Kit for use with EasyRA Analyzer |
| 00386100001803 - CRP Calibrator Kit | 2019-03-11 CRP Calibrator Kit for use with EasyRA Analyzer |
| 00386100001858 - Wash1 Kit | 2019-03-11 Wash1 Kit for use with EasyRA Analyzers |
| 00386100001872 - QC Kit, Level A | 2019-03-11 EasyQC Quality Control Kit - Level for use with EasyRA Analyzer |