TheraPEAK X-VIVO 15 with Recombinant Transferrin 08-996B

GUDID 00840075404514

Lonza Walkersville, Inc.

Ex vivo cell culture medium

• Primary Device ID: 00840075404514
• NIH Device Record Key: 22ea8a0b-61dd-4309-9d71-8743c0c7f9a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraPEAK X-VIVO 15 with Recombinant Transferrin
• Version Model Number: 08-996B
• Catalog Number: 08-996B
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840075404514 [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: 2025-08-14
• Device Publish Date: 2025-08-06

On-Brand Devices [TheraPEAK X-VIVO 15 with Recombinant Transferrin]

• 00840075404514: 08-996B
• 00840075404507: 08-996BS