Catalog Number

-

Brand Name

BodyTrace

Version/Model Number

BT106

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)

-

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

61b20de6-d990-4cef-add3-2aba2b40c8fd

Public Version Date

November 11, 2021

Public Version Number

1

DI Record Publish Date

November 03, 2021

Package DI Number

B726BT1061

Quantity per Package

1

Contains DI Package

B726BT1060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Individual box