| Primary Device ID | 06944413803145 |
| NIH Device Record Key | 9b5e775a-3bbe-41e6-8105-19d18bcf95b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calibrant Fluid Pack |
| Version Model Number | CP50 |
| Company DUNS | 529173163 |
| Company Name | Edan Instruments, Inc. |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06944413802599 [Package] Contains: 06944413803152 Package: [1 Units] In Commercial Distribution |
| GS1 | 06944413803145 [Package] Contains: 06944413802599 Package: [6 Units] In Commercial Distribution |
| GS1 | 06944413803152 [Primary] |
| JIX | Calibrator, Multi-Analyte Mixture |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-01 |
| 06944413803145 | CP50 |
| 06944413803107 | CP100 |