Catalog Number

M7008

Brand Name

ASEPT Peritoneal Drainage System

Version/Model Number

M7008

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

K093796,K093796

Product Code

PNG

Product Code Name

Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Public Device Record Key

3710c98f-84c2-4b0e-9346-640e183dae4f

Public Version Date

September 06, 2019

Public Version Number

4

DI Record Publish Date

October 15, 2015

Package DI Number

10813623017068

Quantity per Package

5

Contains DI Package

00813623017061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-