Catalog Number

-

Brand Name

Guardian Angel™ Rx

Version/Model Number

GA2000Rx-A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

DQA

Product Code Name

Oximeter

Public Device Record Key

2e3f81c6-c5aa-4a8c-8c5d-c79a5d2893c5

Public Version Date

August 15, 2019

Public Version Number

1

DI Record Publish Date

August 07, 2019

Package DI Number

14719872650192

Quantity per Package

1

Contains DI Package

04719872650195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-