Catalog Number

-

Brand Name

Alcedo

Version/Model Number

AE176

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

K200437,K200437

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

e9f7850e-9f24-4a99-a767-c5f613e46a21

Public Version Date

November 12, 2021

Public Version Number

1

DI Record Publish Date

November 04, 2021

Package DI Number

10856471007324

Quantity per Package

20

Contains DI Package

00856471007327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton