| Primary Device ID | 00840075404439 |
| NIH Device Record Key | 2b23ac12-b867-46e7-b8e9-76607b0513c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-VIVO 10 with Gentamycin and Phenol Red |
| Version Model Number | BP04-380Q |
| 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 | 00840075404439 [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 | 2025-01-31 |
| Device Publish Date | 2025-01-23 |
| 00840075404439 - X-VIVO 10 with Gentamycin and Phenol Red | 2025-01-31 |
| 00840075404439 - X-VIVO 10 with Gentamycin and Phenol Red | 2025-01-31 |
| 00840075404446 - TheraPEAK 293-GT Medium | 2025-01-31 |
| 00840075404453 - TheraPEAK 293-GT AAV Supplement | 2025-01-31 |
| 00840075404415 - UltraMDCK Serum Free Medium | 2024-11-27 |
| 00840075404422 - CHO Feed Base L | 2024-11-27 |
| 00840075404361 - Lonza LVV Harvest Adjustment Buffer | 2024-10-10 |
| 00840075404378 - Lonza LVV Conditioning/Strip Buffer | 2024-10-10 |
| 00840075404385 - Lonza LVV Wash2 Buffer | 2024-10-10 |