Catalog Number

M7001

Brand Name

ASEPT Pleural Drainage System

Version/Model Number

M7001

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DWM

Product Code Name

Apparatus, Suction, Patient Care

Public Device Record Key

48ca3f29-2643-43d7-8aff-d12c2c857831

Public Version Date

September 06, 2019

Public Version Number

4

DI Record Publish Date

October 02, 2016

Package DI Number

10813623017013

Quantity per Package

10

Contains DI Package

00813623017016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-