Catalog Number

-

Brand Name

Alcedo

Version/Model Number

B23

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

K172171,K172171

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

9f6dd36a-a323-42a4-8c69-ae2202cf6f11

Public Version Date

October 20, 2020

Public Version Number

1

DI Record Publish Date

October 12, 2020

Package DI Number

10856471007225

Quantity per Package

20

Contains DI Package

00856471007228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-