Synermed®

Basic Information

• Brand Name: Synermed®
• Primary DI: 05060500090678
• Version / Model: UV310-X
• Catalog Number: UV310-X
• 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: 70cf8cbe-89ea-4926-943f-63c7ee2b64a5

Device Description

Creatine Kinase Reagent 1 X 60 mL/1 vial + 1 X 27 mL/1 vial

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
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53006	Total creatine kinase (CK) 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 total creatine kinase (CK) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060500090678	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K930932	000

Storage Conditions

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