A&D Medical - Digital Blood Pressure Monitor. - A&D COMPANY, LIMITED

Duns Number:691722987

Device Description: Digital Blood Pressure Monitor.

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More Product Details

Catalog Number

UA-651BLE, UA-651CNBLE

Brand Name

A&D Medical

Version/Model Number

UA-651BLE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

bcedc402-b740-466d-8ca6-d9e87851e293

Public Version Date

July 31, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10093764603324

Quantity per Package

10

Contains DI Package

00093764603327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"A&D COMPANY, LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 45