Fifty50

Basic Information

• Brand Name: Fifty50
• Primary DI: 00892896000017
• Version / Model: 163140
• Company Name: i-SENS, Inc.
• Labeler DUNS: 688840958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ed837ba6-fcc4-45e7-bda3-1304d24d44dc

Device Description

Fifty50 Blood Glucose Test Strip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53307	Glucose 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 glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20892896000011	GS1	Master Case Carton	2	In Commercial Distribution
Package	10892896000014	GS1	Case Pack (Mid-Box)	250	In Commercial Distribution
Primary	00892896000017	GS1
Unit of Use	50892896000012	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083468	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 33.8 – 86 Degrees Fahrenheit