CeQur Simplicity

Basic Information

• Brand Name: CeQur Simplicity
• Primary DI: 00373108000013
• Version / Model: CQR-S-INS
• 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: 2
• Public Version Date: 2021-11-22
• Public Version Status: Update
• Public Device Record Key: 7c005512-aecd-47b6-9081-ebb7c8b90ab6

Device Description

CeQur Simplicity™ Inserter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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	00373108000013	GS1

Premarket Submissions

Submission Number	Supplement Number
K163357	000