Catalog Number

-

Brand Name

EarlySense® BEX Sensor

Version/Model Number

AME-01610 US

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

K171836,K171836

Product Code

BZQ

Product Code Name

Monitor, Breathing Frequency

Public Device Record Key

71971c0d-8160-45d6-bca9-a74b31e4f118

Public Version Date

August 29, 2018

Public Version Number

1

DI Record Publish Date

July 29, 2018

Package DI Number

17290016169246

Quantity per Package

10

Contains DI Package

07290016169249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-