Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516749640
• Version / Model: 591-4-1000
• Catalog Number: 591-4-1000
• Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY
• Labeler DUNS: 988298840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-20
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 94821eea-60d9-4662-84e5-5ebd1ee6162e

Device Description

Oxalate Sample Diluent

Device Characteristics

• Single Use: No
• 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	05391516749640	GS1

Customer Contacts

• Phone: + 35312769800
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K883525	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1000	Milliliter

Storage Conditions

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