Catalog Number

200-0021-US

Brand Name

AspireAssist Skin-Port Installation Tool Kit-US

Version/Model Number

200-0021-US

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

P150024

Product Code

OYF

Product Code Name

Aspiration Therapy System

Public Device Record Key

9de369a9-61ca-49f3-9915-ec555e4ca090

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-