NS

Basic Information

• Brand Name: NS
• Primary DI: 05055273206111
• Version / Model: SA3854
• Catalog Number: SA3854
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 492e7c1d-caa9-4d64-9fd8-3091cd226279

Device Description

This product should be used in conjunction with RX series reagents to dilute samples prior to assay

Device Characteristics

• Single Use: Yes
• 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
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	862.2170	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43674	Isotonic saline reagent IVD	An unbuffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273206111	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K024014	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Once opened the reagent is stable for 1 month on board the analyser at approximately +10°C.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius