| Primary Device ID | 00386100003111 |
| NIH Device Record Key | 0f711187-c4a1-46ec-92a8-a610c120135a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Na/K/Ca/pH Solution Pack |
| Version Model Number | 2123 |
| Catalog Number | 2123 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 |
| 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 | 00386100003111 [Primary] |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph |
| 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 |
| 00386100003111 | Na/K/Ca/pH Solution Pack for use with EasyLyte Analyzers |
| 00386100003067 | Na/K/Ca/pH Solution Pack for use with EasyLyte Analyzers |