KENTEX - FULLY AUTOMATIC ARM BLOOD PRESSURE MONITOR - KENTRON HEALTHCARE, INC.

Duns Number:618825723

Device Description: FULLY AUTOMATIC ARM BLOOD PRESSURE MONITOR

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

791305

Brand Name

KENTEX

Version/Model Number

791305

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

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

158ba051-1a91-4ac3-921f-c1096a98898d

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KENTRON HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 155