TriniCLOT™ Factor XII

Basic Information

• Brand Name: TriniCLOT™ Factor XII
• Primary DI: 15391521420449
• Version / Model: T1512
• Company Name: TCOAG IRELAND LIMITED
• Labeler DUNS: 985039126
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: af9545df-a999-46a3-88f1-be86f6e09da0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
GJT	Plasma, Coagulation Factor Deficient	Hematology	864.7290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56043	Coagulation factor XII IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor XII in a clinical specimen, using a clotting method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15391521420449	GS1
Unit of Use	05391521420442	GS1

Premarket Submissions

Submission Number	Supplement Number
K893534	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius