Catalog Number

BL1218

Brand Name

BREEZE® SECUREMENT

Version/Model Number

BL1218

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"

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

-

Product Code

KMK

Product Code Name

DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Public Device Record Key

4b9fdcac-7647-4903-b84a-fece92aef5d8

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 26, 2022

Package DI Number

30884908140805

Quantity per Package

25

Contains DI Package

00884908140804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner box