Catalog Number

-

Brand Name

SECQURE Ultimate

Version/Model Number

CQ3442ULT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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"

-

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

K081398

Product Code

KGY

Product Code Name

Bag, Intestine

Public Device Record Key

0d03c33a-25ed-4661-b2f8-91596b1dbce4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-