CeQur Simplicity

GUDID 00373108000037

CeQur Simplicity™ Starter Kit

CEQUR CORPORATION

Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00373108000037
• NIH Device Record Key: 48e9464c-b2be-40f7-9ad7-186de3bcff93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CeQur Simplicity
• Version Model Number: CQR-S-2US
• Company DUNS: 002270730
• Company Name: CEQUR CORPORATION
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00373108000037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163357

FDA Product Code

• OPP: Pump, Infusion, Insulin Bolus

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: 2021-08-30
• Device Publish Date: 2021-08-22

On-Brand Devices [CeQur Simplicity]

• 00373108000037: CeQur Simplicity™ Starter Kit
• 00373108000020: CeQur Simplicity™ Inserter
• 00373108000006: CeQur Simplicity™ 3-Day Insulin Delivery Patch (1 Patch)
• 00373108000013: CeQur Simplicity™ Inserter