Catalog Number

989803104611

Brand Name

Cardiac Output Adapter Cable

Version/Model Number

CBL Cardiac Output Cable

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)

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

a803bef3-3360-41ba-8522-fb469acb7ec5

Public Version Date

August 11, 2022

Public Version Number

3

DI Record Publish Date

June 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-