TheraPEAK X-Vivo 10 Contains Recombinant Transferrin BP02-055Q

GUDID 00840075404040

Lonza Walkersville, Inc.

Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD Cell culture medium IVD

• Primary Device ID: 00840075404040
• NIH Device Record Key: 9500192c-9688-4067-8424-8358628e6e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraPEAK X-Vivo 10 Contains Recombinant Transferrin
• Version Model Number: BP02-055Q
• Catalog Number: BP02-055Q
• 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	00840075404040 [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: 2023-04-21
• Device Publish Date: 2023-04-13

Devices Manufactured by Lonza Walkersville, Inc.

• 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