Catalog Number

-

Brand Name

NA

Version/Model Number

95185-001

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

K924208

Product Code

DPT

Product Code Name

PROBE, BLOOD-FLOW, EXTRAVASCULAR

Public Device Record Key

db09b5f0-7b37-4ca0-8c74-0cf67f69e988

Public Version Date

October 10, 2018

Public Version Number

4

DI Record Publish Date

January 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-