Catalog Number

-

Brand Name

moorFLPI-2 Clinical PC Software

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2022

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

K122943

Product Code

DPT

Product Code Name

Probe, Blood-Flow, Extravascular

Public Device Record Key

47fad94a-8e96-4962-aff4-d5d73e7b05d4

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

December 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-