CeQur Simplicity

Primary DI
00373108000020
Brand
CeQur Simplicity
Company
CEQUR CORPORATION
Model
CQR-S-INS
Device description
CeQur Simplicity™ Inserter
Published
2021-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OPPPump, Infusion, Insulin Bolus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPPPump, Infusion, Insulin BolusGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163357000OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH2017-06-07OPP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00373108000020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00373108000020003731080000203731080000200373108000020

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump reservoirAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002270730
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00373108000006CeQur SimplicityCQR-S-2U012021-08-22
00373108000013CeQur SimplicityCQR-S-INS2021-08-22
00373108000037CeQur SimplicityCQR-S-2US2021-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00373108000013CeQur SimplicityCEQUR CORPORATIONOPP2021-08-22
00373108000006CeQur SimplicityCEQUR CORPORATIONOPP2021-08-22
00373108000037CeQur SimplicityCEQUR CORPORATIONOPP2021-08-22