CareSens N

Basic Information

• Brand Name: CareSens N
• Primary DI: 00885325000023
• Version / Model: 164104-203
• Catalog Number: 164104-203, 164104-205
• Company Name: i-SENS, Inc.
• Labeler DUNS: 688840958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-01-11
• Public Version Status: Update
• Public Device Record Key: 8c992cb6-c08c-4c28-a9cb-ec923b71e79d

Device Description

CareSens N 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	20885325000027	GS1	Master Case Carton	10	In Commercial Distribution
Package	10885325000020	GS1	Case Pack (Mid-Box)	50	In Commercial Distribution
Primary	00885325000023	GS1
Unit of Use	50885325000028	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