| Primary Device ID | 00840075403968 |
| NIH Device Record Key | 56d82d1a-bc73-47e0-8186-89abf1b09280 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-VIVO 10 without Gentamycin without Phenol Red |
| Version Model Number | 08-979Y |
| Catalog Number | 08-979Y |
| Company DUNS | 609095955 |
| Company Name | Lonza Walkersville, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840075403968 [Primary] |
| KIT | Media And Components, Synthetic Cell And Tissue Culture |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-10 |
| Device Publish Date | 2023-02-02 |
| 00840075404248 - CHO Medium 4A, 8902g | 2024-04-04 |
| 00840075404217 - UltraCulture | 2024-03-20 |
| 00840075404224 - UltraCulture | 2024-03-20 |
| 00840075404231 - UltraCulture | 2024-03-20 |
| 00840075404200 - TheraPEAK® MSCGM® Supplement | 2023-11-23 |
| 00840075403920 - 1X PBS, pH 7.4 200L | 2023-08-09 |
| 00840075404125 - TE Buffer (pH 7.90 + 0.30) | 2023-08-04 |
| 00840075404132 - 2M Calcium Chloride | 2023-08-04 |