KnockOut™ Serum Replacement

GUDID 10190302001588

LIFE TECHNOLOGIES CORPORATION

Ex vivo cell culture medium

• Primary Device ID: 10190302001588
• NIH Device Record Key: 3c6446b8-06fe-4e2c-8bba-e33a54006df5
• Commercial Distribution Discontinuation: 2020-08-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: KnockOut™ Serum Replacement
• Version Model Number: 10828028
• 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	10190302001588 [Primary]
GS1	30190302001582 [Package]; Package: Case [10 Units]; Discontinued: 2020-08-07; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100616

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: 7
• Public Version Date: 2020-08-10
• Device Publish Date: 2016-08-01

On-Brand Devices [KnockOut™ Serum Replacement]

• 10190302001588: 10828028
• 10190302001571: 10828010