Catalog Number

-

Brand Name

CARDIO 1st

Version/Model Number

BS-2001-G1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2021

Issuing Agency

In GS1

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

FRI

Product Code Name

Scale, Stand-On, Patient

Public Device Record Key

0339cd4e-0f62-45cd-ac5f-027b6475d791

Public Version Date

October 08, 2021

Public Version Number

1

DI Record Publish Date

September 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-