Catalog Number

-

Brand Name

TOPCARE

Version/Model Number

52-50K

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

DQA

Product Code Name

Oximeter

Public Device Record Key

3db3284c-f0c9-49a1-a14e-6fa7e5d9222c

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

August 04, 2020

Package DI Number

10036800023427

Quantity per Package

24

Contains DI Package

00036800023420

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON