OpTmizer™ CTS™ T-Cell Expansion Basal Medium

GUDID 10190302005135

LIFE TECHNOLOGIES CORPORATION

Ex vivo cell culture medium

• Primary Device ID: 10190302005135
• NIH Device Record Key: 8ac0146e-214b-4dfc-88e0-96c79e9e0fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OpTmizer™ CTS™ T-Cell Expansion Basal Medium
• Version Model Number: A1022101
• Company DUNS: 118793157
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190302005135 [Primary]
GS1	30190302005139 [Package]; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113566

FDA Product Code

• NDS: MEDIA, CULTURE, EX VIVO, TISSUE AND CELL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-24
• Device Publish Date: 2016-08-01

On-Brand Devices [OpTmizer™ CTS™ T-Cell Expansion Basal Medium]

• 10190302005135: A1022101
• 10190302005142: A1022103