Catalog Number

590-HT12BMS

Brand Name

Health-Tec Biological Monitoring System

Version/Model Number

590-HT12BMS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

55857eca-3ede-40da-9cc1-939cde7ae850

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 24, 2017

Package DI Number

D773590HT12BMS3

Quantity per Package

6

Contains DI Package

D773590HT12BMS1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-