Catalog Number

896625022

Brand Name

TRUWAVE CABLES

Version/Model Number

PX1800

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142749

Product Code

DXO

Product Code Name

Transducer, Pressure, Catheter Tip

Public Device Record Key

c04301a4-6170-4aec-96f5-0b195175048f

Public Version Date

August 03, 2020

Public Version Number

1

DI Record Publish Date

July 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-