Catalog Number

902-637

Brand Name

N/A

Version/Model Number

Custom

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K780479,K780479

Product Code

KRA

Product Code Name

Catheter, Continuous Flush

Public Device Record Key

f81cbc24-507e-460c-b305-e805d872a216

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

H6719026371

Quantity per Package

25

Contains DI Package

H6719026370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box