Catalog Number

15508

Brand Name

Alcavis 50

Version/Model Number

250 mL

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

-

Product Code

KDJ

Product Code Name

Set, Administration, For Peritoneal Dialysis, Disposable

Public Device Record Key

9b18a9de-f6a6-4528-af38-2417c23a57d7

Public Version Date

March 19, 2021

Public Version Number

5

DI Record Publish Date

August 29, 2016

Package DI Number

30898021000045

Quantity per Package

24

Contains DI Package

00898021000044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case