Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516744546
• Version / Model: Enzyme Cleaner Tube
• Catalog Number: 01-12-0001
• Company Name: PRIMUS CORPORATION
• Labeler DUNS: 790074793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8167b124-42c3-4b4d-8696-19383a24bccc

Device Description

Hemoglobin A1c assay, Enzyme Cleaner Tube

Device Characteristics

• Single Use: Yes
• 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: 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
LCP	Assay, Glycosylated Hemoglobin	Hematology	864.7470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38773	Medical device-decontamination agent	A non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, surgical instruments/devices, and/or laboratory analysers/instruments for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516744546	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K891235	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 28 Degrees Celsius