Catalog Number

026-20226A

Brand Name

Cycler Drain Bag Set

Version/Model Number

026-20226A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173363,K173363

Product Code

KDJ

Product Code Name

Set, Administration, For Peritoneal Dialysis, Disposable

Public Device Record Key

47336087-4f6f-48ee-b110-2edef872ab2a

Public Version Date

June 19, 2019

Public Version Number

1

DI Record Publish Date

June 11, 2019

Package DI Number

10840861102034

Quantity per Package

10

Contains DI Package

00840861102037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-