Catalog Number

2099000-003

Brand Name

NA

Version/Model Number

B105 Patient Monitor

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K201941

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Public Device Record Key

d40c9feb-d45c-4b40-b84f-beceea4f7101

Public Version Date

April 27, 2022

Public Version Number

3

DI Record Publish Date

November 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-