Synermed®

Basic Information

• Brand Name: Synermed®
• Primary DI: 05060500090869
• Version / Model: IR059-WK
• Catalog Number: IR059-WK
• Company Name: INFRARED LABORATORY SYSTEMS LLC
• Labeler DUNS: 014210494
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a36842b5-bed2-467c-b35e-1541eb7eb077

Device Description

LDL-Cholesterol Reagent 1 X 25 mL + 1 X 8.4 mL

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: 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
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	862.1475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53398	Low density lipoprotein (LDL) cholesterol 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 low density lipoprotein (LDL) cholesterol lipid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060500090869	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072523	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 4 Degrees Celsius