Catalog Number

-

Brand Name

CeQur Simplicity

Version/Model Number

CQR-S-2U01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163357,K163357

Product Code

LZG

Product Code Name

Pump, Infusion, Insulin

Public Device Record Key

db1e098d-1cd1-422e-9a93-af5e16718131

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 22, 2021

Package DI Number

10373108000003

Quantity per Package

10

Contains DI Package

00373108000006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box