Catalog Number

03-2962-3

Brand Name

CombiSet

Version/Model Number

03-2962-3

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"

Yes

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

K070049,K070049

Product Code

ONW

Product Code Name

Hemodialysis system for home use

Public Device Record Key

dfa1938b-6959-4afd-bba1-3e4ba2217ab2

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

10840861100337

Quantity per Package

24

Contains DI Package

00840861100330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-