Catalog Number

3112357182

Brand Name

Roche 9180 SNAPPAK 9180/9181 DIALYSATE TYPE

Version/Model Number

3112357182

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JGS

Product Code Name

ELECTRODE, ION SPECIFIC, SODIUM

Public Device Record Key

65c7bb7b-8617-487d-9111-551b032a1189

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-