Catalog Number

SP6000GE003

Brand Name

GETINGE 6000

Version/Model Number

SP-6000

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

107ed032-5e6c-4e23-84ff-759a3a410ec3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-