Catalog Number

YS-116P8

Brand Name

N/A

Version/Model Number

YS-116P8

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

K203435

Product Code

MHX

Product Code Name

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Public Device Record Key

fdd39ce3-99ad-4558-8a29-5e5911c6497a

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

September 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-