KENAFLEXX - NON INVASIVE BLOOD PRESSURE NYLON CUFF ADULT - KENTRON HEALTHCARE, INC.

Duns Number:618825723

Device Description: NON INVASIVE BLOOD PRESSURE NYLON CUFF ADULT DOUBLE TUBE

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More Product Details

Catalog Number

177811D

Brand Name

KENAFLEXX

Version/Model Number

177811D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

ffccbe04-1ffa-4aff-834d-bf797be20272

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

October 02, 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