Catalog Number

87-655-001

Brand Name

TOPCARE

Version/Model Number

87-655-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

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

7b6c5c1b-deab-4ca6-809a-08114109e4b6

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

10036800334110

Quantity per Package

12

Contains DI Package

00036800334113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner/Master Carton