CareSens S Fit

GUDID 00885325001518

CareSens S Fit Blood Glucose Monitoring System

i-SENS, Inc.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 00885325001518
• NIH Device Record Key: 413b4a13-fdc5-4ac2-8011-d5903851d0cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareSens S Fit
• Version Model Number: 164506
• Company DUNS: 688840958
• Company Name: i-SENS, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885325001518 [Primary]
GS1	10885325001515 [Package]; Package: Master Case Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180866

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-19
• Device Publish Date: 2023-07-11

Devices Manufactured by i-SENS, Inc.

• 10885325000853 - KetoSens: 2023-08-03 KetoSens B-Ketone Monitoring System with Lancets
• 10885325001492 - KetoSens: 2023-08-03 KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)
• 10885325001188 - CareSens S Fit BT: 2023-07-19 CareSens S Fit BT Blood Glucose Monitoring System
• 00885325001518 - CareSens S Fit: 2023-07-19CareSens S Fit Blood Glucose Monitoring System
• 00885325001518 - CareSens S Fit: 2023-07-19 CareSens S Fit Blood Glucose Monitoring System
• 10885325001768 - CareSens N Voice Square: 2023-07-19 CareSens N Voice Square Blood Glucose Monitoring System
• 10885325001683 - CareSens N Feliz BT: 2022-07-26 CareSens N Feliz BT Blood Glucose Monitoring System
• 10885325001690 - CareSens N Feliz: 2022-07-26 CareSens N Feliz Blood Glucose Monitoring System
• 10885325001386 - Tempo: 2021-02-25 Tempo Blood Glucose Monitoring System