Catalog Number

-

Brand Name

N/A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171580

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Public Device Record Key

2c950fd9-dc3f-495e-bc40-f7b7f2fad216

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

November 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-