Catalog Number

FD1600-001

Brand Name

GETINGE 1600-SERIES

Version/Model Number

FD1600

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FLH

Product Code Name

Washer Of Body Waste Receptacles

Public Device Record Key

4315f458-db51-44db-9d05-45799d98b7fe

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-