TheraPEAK® X-VIVO® 15 without Gentamycin or Phenol Red 08-988H

GUDID 00840075404118

Lonza Walkersville, Inc.

Cell culture medium IVD

• Primary Device ID: 00840075404118
• NIH Device Record Key: 90121b03-bdac-40c0-acff-cf060826db2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraPEAK® X-VIVO® 15 without Gentamycin or Phenol Red
• Version Model Number: 08-988H
• Catalog Number: 08-988H
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840075404118 [Primary]

FDA Product Code

• KIT: Media And Components, Synthetic Cell And Tissue Culture

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

Devices Manufactured by Lonza Walkersville, Inc.

• 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