Catalog Number

-

Brand Name

Wyltec

Version/Model Number

W03-01001PUR

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082542

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

4d65e760-d94e-4507-93c1-f806e55b3ffe

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-