Catalog Number

SU130-1348

Brand Name

CARDINAL HEALTH

Version/Model Number

SU130-1348

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"

-

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

c84f5bf1-c310-4b58-b0df-9155e6ddba28

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

May 27, 2020

Package DI Number

50192253022498

Quantity per Package

10

Contains DI Package

10192253022490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE