Catalog Number

5PS-050

Brand Name

9Line

Version/Model Number

5PS-050

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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"

Yes

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

-

Product Code

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Public Device Record Key

ff3cca32-02da-4117-804a-660f756a4efd

Public Version Date

March 01, 2022

Public Version Number

1

DI Record Publish Date

February 21, 2022

Package DI Number

G0965PS0505

Quantity per Package

50

Contains DI Package

G0965PS0500

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX