CONTOUR® NEXT 9697

GUDID 40301939697018

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabetes. This kit contains the following items: CONTOUR® Next Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case; CONTOUR® NEXT Control Solution; Warranty Card.

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 40301939697018
• NIH Device Record Key: 23d2ecae-fbfd-4a0b-bb17-a5de41ff5af8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOUR® NEXT
• Version Model Number: 9697
• Catalog Number: 9697
• Company DUNS: 080028910
• Company Name: ASCENSIA DIABETES CARE US 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 18003488100
• Email: support@contournext.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301939697010 [Primary]
NDC/NHRIC	0193-9697-01 [Secondary]
GS1	40301939697018 [Package]; Contains: 00301939697010; Package: shipper/case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121190

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [CONTOUR® NEXT]

• 40301939697018: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabete
• 40301937379015: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood gl
• 40301937377011: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood gl
• 40301937283350: Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 1030193731025
• 10301937313100: Blood Glucose Test Strips - 10 Test Strips.
• 40301939737219: Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 tes
• 40301939736502: Blood Glucose Test Strips - 50 Test Strips.
• 40301939735253: Blood Glucose Test Strips - 25 Test Strips.
• 40301937357501: Blood Glucose Test Strips - 50 Test Strips.
• 40301937308503: Blood Glucose Test Strips - 50 Test Strips.
• 50301937315010: Control Solution - Level 1. 1 x 2.5 mL.
• 50301937314013: Control Solution - Level 2. 1 x 2.5 mL.
• 40301937278707: Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test
• 40301937277359: Blood Glucose Test strips. 35 test strips.