CeQur Simplicity

GUDID 00373108000006

CeQur Simplicity™ 3-Day Insulin Delivery Patch (1 Patch)

CEQUR CORPORATION

Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00373108000006
• NIH Device Record Key: db1e098d-1cd1-422e-9a93-af5e16718131
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CeQur Simplicity
• Version Model Number: CQR-S-2U01
• Company DUNS: 002270730
• Company Name: CEQUR CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00373108000006 [Primary]
GS1	10373108000003 [Package]; Package: Box [10 Units]; In Commercial Distribution

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: true

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