Catalog Number

M7000

Brand Name

ASEPT Peritoneal Drainage System

Version/Model Number

M7000

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)

Yes

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

-

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

ceab0a96-f227-45f0-8ab3-9cc33c7c0351

Public Version Date

September 06, 2019

Public Version Number

5

DI Record Publish Date

October 15, 2015

Package DI Number

10813623015378

Quantity per Package

10

Contains DI Package

00813623015371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-