CTS™ AIM-V™ Medium

Basic Information

• Brand Name: CTS™ AIM-V™ Medium
• Primary DI: 10190302014250
• Version / Model: A3830801
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Labeler DUNS: 118793157
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-13
• Public Version: 7
• Public Version Date: 2020-08-11
• Public Version Status: Update
• Public Device Record Key: aa27db88-30bb-4e3c-b3ab-d6d2ffa0a182
• Distribution End Date: 2020-08-10

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDS	MEDIA, CULTURE, EX VIVO, TISSUE AND CELL	Gastroenterology, Urology	876.5885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58567	Cell culture medium IVD	A liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30190302014254	GS1	Case	6	Not in Commercial Distribution	2020-08-10
Primary	10190302014250	GS1

Premarket Submissions

Submission Number	Supplement Number
K022086	000