Catalog Number

-

Brand Name

Technicuff

Version/Model Number

UT-3962L

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

K942259

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

b9430d54-c190-40c0-a541-76fb00b87507

Public Version Date

August 17, 2018

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-