Catalog Number

-

Brand Name

Guardian Angel™ Rx

Version/Model Number

GA1000-A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 17, 2019

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

4ac21ace-6d04-4a27-ab1d-9e0f370f412d

Public Version Date

December 16, 2019

Public Version Number

3

DI Record Publish Date

April 13, 2019

Package DI Number

14719872650055

Quantity per Package

1

Contains DI Package

04719872650058

Package Discontinue Date

May 17, 2019

Package Status

Not in Commercial Distribution

Package Type

-