Catalog Number

AK-01000

Brand Name

ARROW

Version/Model Number

IPN033837

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K870572,K870572

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

e96bd2a0-2707-415f-8fad-2d1d9ba22c15

Public Version Date

March 08, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

30801902004780

Quantity per Package

10

Contains DI Package

00801902004789

Package Discontinue Date

March 01, 2019

Package Status

Not in Commercial Distribution

Package Type

Case