Catalog Number

100-0011-US

Brand Name

AspireAssist A-Tube Kit

Version/Model Number

100-0011-US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

c7f68483-0358-4eca-83d7-b825b9893bbc

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

July 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-