Catalog Number

-

Brand Name

Dualex Plus Transducer Protector

Version/Model Number

SLGVS25PS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 30, 2017

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

K934069

Product Code

FIB

Product Code Name

Protector, Transducer, Dialysis

Public Device Record Key

2086708d-8b06-4dbc-bd1d-8bfc9a54e3c3

Public Version Date

May 11, 2022

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-