Hokanson - Calculating Cuff Inflator-Data Link Version - A - D.E.HOKANSON, INC.

Duns Number:071829634

Device Description: Calculating Cuff Inflator-Data Link Version - A portable cuff inflator with an electronic Calculating Cuff Inflator-Data Link Version - A portable cuff inflator with an electronic memory and calculator used to measure segmental limb systolic pressures and calculate pressure indices. Inflation and deflation are controlled by the clinician. Measured pressure readings can be stored in memory registers of the device, or sent directly to a computer. The instrument is powered by rechargeable batteries.

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More Product Details

Catalog Number

00932

Brand Name

Hokanson

Version/Model Number

TD312DL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2017

Issuing Agency

In GS1

Product Characteristics

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

K842067

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

3963dbd3-0e61-4caf-ad8f-40934c9afc51

Public Version Date

October 05, 2020

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"D.E.HOKANSON, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 218