Catalog Number

-

Brand Name

ZOOM Aspiration Pump

Version/Model Number

TAP1B

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

-

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

K190105

Product Code

JCX

Product Code Name

Apparatus, Suction, Ward Use, Portable, Ac-Powered

Public Device Record Key

7eef37d3-0fce-40ea-8365-e944840ac185

Public Version Date

March 25, 2019

Public Version Number

1

DI Record Publish Date

March 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-