TheraPEAK® MSCGM® Supplement BP13-935J

GUDID 00840075404200

Lonza Walkersville, Inc.

Ex vivo cell culture medium

• Primary Device ID: 00840075404200
• NIH Device Record Key: e649c269-5dfb-48ef-b2c1-3a4c5490e648
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraPEAK® MSCGM® Supplement
• Version Model Number: BP13-935J
• Catalog Number: BP13-935J
• 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	00840075404200 [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: 2023-11-23
• Device Publish Date: 2023-11-15

Devices Manufactured by Lonza Walkersville, Inc.

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• 00840075404538 - TheraPRO CHO Expansion Medium: 2025-09-22
• 00840075404507 - TheraPEAK X-VIVO 15 with Recombinant Transferrin: 2025-08-14
• 00840075404514 - TheraPEAK X-VIVO 15 with Recombinant Transferrin: 2025-08-14
• 00840075404460 - GS2-N Low B12, No Hydrocortisone: 2025-05-20
• 00840075404477 - R34 Low B12: 2025-05-20
• 00840075404484 - F30 Low B12, No Hydrocortisone: 2025-05-20
• 00840075404491 - R34 Low B12: 2025-05-20