Catalog Number

-

Brand Name

Alcedo

Version/Model Number

AE169

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

ba8a52ff-662d-4851-83e1-2a85be2ef43c

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

July 16, 2019

Package DI Number

10856471007089

Quantity per Package

10

Contains DI Package

00856471007082

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton