Catalog Number

-

Brand Name

GLOBAL HEALTHCARE

Version/Model Number

84-2-12S

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

34b7db39-eb46-4f5d-a0dd-f824761956a8

Public Version Date

August 06, 2020

Public Version Number

3

DI Record Publish Date

November 14, 2017

Package DI Number

00872237003310

Quantity per Package

1

Contains DI Package

00872237003310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pouch