Catalog Number

474-110P

Brand Name

Thermodilution 7FR 110cm Modified J-tip

Version/Model Number

474-110P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

K920869

Product Code

DYG

Product Code Name

Catheter, Flow Directed

Public Device Record Key

717caa6b-8e83-48c0-9e36-86ac55af8090

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

October 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-