Catalog Number

041300003A

Brand Name

Flush Device

Version/Model Number

041300003A

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

K070384,K070384

Product Code

KRA

Product Code Name

Catheter, Continuous Flush

Public Device Record Key

8ba2a03f-a033-48c7-b2f7-ded0ec9774f6

Public Version Date

January 23, 2019

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

20886333201567

Quantity per Package

25

Contains DI Package

00886333201563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box