Catalog Number

-

Brand Name

Heart and Respiration Rate Monitoring System powered by EarlySense

Version/Model Number

P200898

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

K180079,K180079

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Public Device Record Key

9db609e7-8d83-4656-a8f1-cd6f24217a51

Public Version Date

September 24, 2021

Public Version Number

5

DI Record Publish Date

August 22, 2018

Package DI Number

00887761975729

Quantity per Package

1

Contains DI Package

00887761985155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-