Catalog Number

200-0019-LANG A

Brand Name

AspireAssist Connector-LANG A

Version/Model Number

200-0019-LANG A

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

P150024,P150024

Product Code

OYF

Product Code Name

Aspiration Therapy System

Public Device Record Key

598ed9a7-8758-4fbd-aa0f-e8ccebe0546c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 25, 2016

Package DI Number

20857808005058

Quantity per Package

10

Contains DI Package

10857808005051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-