Catalog Number

AI-01600

Brand Name

ARROW

Version/Model Number

IPN032602

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

K895516,K895516

Product Code

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

5c3471c6-0038-4b82-a93b-ce67d7ed8745

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

30801902097904

Quantity per Package

5

Contains DI Package

00801902097903

Package Discontinue Date

February 02, 2018

Package Status

Not in Commercial Distribution

Package Type

Case