Catalog Number

CD-WR17

Brand Name

Wide Range D-Ring Cuff 9" to 17"

Version/Model Number

CD-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

K133379,K133379

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

3cc8a653-56cc-4268-8a94-644e10225aa5

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10073796343177

Quantity per Package

20

Contains DI Package

00073796343170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case