UltraTRAK TM 50 Test Strips

Basic Information

• Brand Name: UltraTRAK TM 50 Test Strips
• Primary DI: 00385930011013
• Version / Model: TD-4255&TD-4275
• Company Name: VERTEX DIAGNOSTICS LLC
• Labeler DUNS: 808107788
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-23
• Public Version: 1
• Public Version Date: 2020-01-31
• Public Version Status: New
• Public Device Record Key: deb9d13c-5dd3-4436-9489-5488829afd4e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385930011013	GS1

Premarket Submissions

Submission Number	Supplement Number
K082618	000