Catalog Number

SC-14703

Brand Name

ARROW

Version/Model Number

IPN033596

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

KGZ

Product Code Name

ACCESSORIES, CATHETER

Public Device Record Key

b7440fc8-9b5a-4591-9769-3862888c4296

Public Version Date

July 22, 2019

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

30801902101601

Quantity per Package

25

Contains DI Package

00801902101600

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case