Catalog Number

-

Brand Name

BIS module kit(Package/no accessory)

Version/Model Number

115-048957-00

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

K170876

Product Code

MHX

Product Code Name

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Public Device Record Key

55e2d9fe-fcde-4f2f-89cc-af121b22ae6f

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

May 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-