Catalog Number

AB1251_US

Brand Name

Advance Biometrix

Version/Model Number

AB1251

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

-

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

5f87bd0f-3962-44dc-9833-1d190729ab4e

Public Version Date

April 13, 2022

Public Version Number

3

DI Record Publish Date

August 26, 2021

Package DI Number

B353AB12512

Quantity per Package

25

Contains DI Package

B353AB12511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Small Box