CTS™ OpTmizer™ T-Cell Expansion Basal Medium

GUDID 30190302014278

LIFE TECHNOLOGIES CORPORATION

Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium Ex vivo cell culture medium

Primary Device ID	30190302014278
NIH Device Record Key	7c709e70-ef89-4cbf-97b6-d314f17aa99b
Commercial Distribution Status	In Commercial Distribution
Brand Name	CTS™ OpTmizer™ T-Cell Expansion Basal Medium
Version Model Number	A3704001
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	10190302014274 [Primary]
GS1	30190302014278 [Package] Contains: 10190302014274 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	5
Public Version Date	2019-11-18
Device Publish Date	2018-06-15

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

10190302014281	A3704003
30190302014278	A3704001