TriniCLOT™ Automated aPTT 3 mL

Basic Information

• Brand Name: TriniCLOT™ Automated aPTT 3 mL
• Primary DI: 15391521420340
• Version / Model: T1206
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 35f08d78-e57c-4912-949d-6efd84446312

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: Yes
• 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
GFO	Activated Partial Thromboplastin	Hematology	864.7925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55981	Activated partial thromboplastin time (APTT) IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of the activated partial thromboplastin time (APTT) of 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	15391521420340	GS1
Unit of Use	05391521420343	GS1

Storage Conditions

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