Catalog Number

-

Brand Name

n.a.

Version/Model Number

30-55-501

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 09, 2022

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

-

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

583b00d4-70fc-4909-a161-f720ebbf3ad8

Public Version Date

February 10, 2022

Public Version Number

2

DI Record Publish Date

August 31, 2020

Package DI Number

14250105612933

Quantity per Package

1

Contains DI Package

04250105612936

Package Discontinue Date

February 09, 2022

Package Status

Not in Commercial Distribution

Package Type

-