Catalog Number

009-004789-00

Brand Name

5-Lead,New Telemetry,IEC,Pinch,36″

Version/Model Number

EY6506A

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"

Yes

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

K150632

Product Code

MSX

Product Code Name

System,Network And Communication,Physiological Monitors

Public Device Record Key

46b212c0-44f2-40ba-8f71-59d7c476f543

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

October 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-