Catalog Number

SU130-1305

Brand Name

CARDINAL HEALTH

Version/Model Number

SU130-1305

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

GCY

Product Code Name

APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Public Device Record Key

0d480ba0-9a94-43d4-a7dc-6a6b19918022

Public Version Date

July 23, 2018

Public Version Number

2

DI Record Publish Date

May 10, 2018

Package DI Number

20885380061490

Quantity per Package

10

Contains DI Package

10885380061493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX