Catalog Number

M7030

Brand Name

ASEPT Peritoneal Drainage System

Version/Model Number

M7030

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

K093796,K093796,K093796

Product Code

FJS

Product Code Name

Catheter, Peritoneal, Long-Term Indwelling

Public Device Record Key

cfd8dfe2-7eff-4105-aff8-fa09e7cc03ea

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 15, 2015

Package DI Number

20813623011117

Quantity per Package

200

Contains DI Package

10813623011110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-