Catalog Number

-

Brand Name

Alcedo

Version/Model Number

AE174

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140582,K140582

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

93811b5a-b92c-4052-9c23-88e4bd25fa8f

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

April 06, 2020

Package DI Number

10856471007201

Quantity per Package

100

Contains DI Package

00856471007204

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton