Catalog Number

CFX-WR17

Brand Name

Easy Wrap Comfit Cuff 9"-17"

Version/Model Number

CFX-WR17

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133383,K133383

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

f94faf42-e6cc-4825-8f06-d769757c8c5d

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10073796364172

Quantity per Package

20

Contains DI Package

00073796364175

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case