Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516742207
• Version / Model: 591-20
• Catalog Number: 591-20
• Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY
• Labeler DUNS: 988298840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2017-10-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 11856c72-4127-43d0-ba42-64337ce381ce

Device Description

Sample Purifier Tubes

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
LPW	System, Test, Oxalate	Clinical Chemistry	862.1542	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53506	Oxalate IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of oxalate in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516742207	GS1
Unit of Use	05391516749602	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K883525	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20 Tubes

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 26 Degrees Celsius