Catalog Number

AME-00200 US

Brand Name

EarlySense® Contact-Free Sensor

Version/Model Number

N/A

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

K131379,K131379

Product Code

BZQ

Product Code Name

Monitor, Breathing Frequency

Public Device Record Key

29727e3b-34c0-4edc-a104-db0ff519cda9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 15, 2017

Package DI Number

17290016169017

Quantity per Package

10

Contains DI Package

07290016169010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-