Catalog Number

-

Brand Name

Actril Cold Sterilant

Version/Model Number

78337-000

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K861730,K861730

Product Code

FKQ

Product Code Name

System, Dialysate Delivery, Central Multiple Patient

Public Device Record Key

26353a3f-60e0-4ecb-b79e-d2451f709c90

Public Version Date

April 27, 2022

Public Version Number

5

DI Record Publish Date

February 26, 2018

Package DI Number

30677964000240

Quantity per Package

4

Contains DI Package

00677964000249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box