Catalog Number

-

Brand Name

Kew Medical

Version/Model Number

QEG4170

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 15, 2017

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

K925430,K925430

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

da12284d-d82a-40d6-bca6-a0326b97bb2f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-