Catalog Number

K71

Brand Name

CARDINAL HEALTH

Version/Model Number

K71

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

GCX

Product Code Name

APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Public Device Record Key

4a77f9e3-6704-420b-9d9c-2e09e4bdbd3c

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

August 26, 2016

Package DI Number

50630140041059

Quantity per Package

50

Contains DI Package

20630140041058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE