Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-322160

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

559e5c77-d4dd-4dfc-a428-e88da57107fd

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

September 30, 2019

Package DI Number

00612479247956

Quantity per Package

10

Contains DI Package

00612479247949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case