Catalog Number

989803104621

Brand Name

Cardiac Output Adapter Cable

Version/Model Number

Cardiac Output Cable, 4.8m

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

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

-

Product Code

DRT

Product Code Name

MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Public Device Record Key

402f23b8-4f18-4545-972f-75b18af5bfbc

Public Version Date

September 23, 2022

Public Version Number

4

DI Record Publish Date

October 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-