Catalog Number

-

Brand Name

Bernoulli

Version/Model Number

Bernoulli One Software

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

K091461

Product Code

MSX

Product Code Name

System,Network And Communication,Physiological Monitors

Public Device Record Key

52fb984b-6453-4f40-85a9-fe316474bc0d

Public Version Date

November 09, 2021

Public Version Number

5

DI Record Publish Date

December 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-