CeQur Simplicity

Basic Information

• Brand Name: CeQur Simplicity
• Primary DI: 00373108000006
• Version / Model: CQR-S-2U01
• Company Name: CEQUR CORPORATION
• Labeler DUNS: 002270730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-22
• Public Version: 1
• Public Version Date: 2021-08-30
• Public Version Status: New
• Public Device Record Key: db1e098d-1cd1-422e-9a93-af5e16718131

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OPP	Pump, Infusion, Insulin Bolus	General Hospital	880.5725	2
LZG	Pump, Infusion, Insulin	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35838	Ambulatory insulin infusion pump reservoir	An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00373108000006	GS1
Package	10373108000003	GS1	Box	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K163357	000