Catalog Number

15501

Brand Name

Alcavis 50

Version/Model Number

500 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

59672136-1223-42f7-823e-6c6922042b93

Public Version Date

March 19, 2021

Public Version Number

5

DI Record Publish Date

August 29, 2016

Package DI Number

20898021000055

Quantity per Package

12

Contains DI Package

00898021000051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case