Hokanson - A battery powered remote timer used by a - D.E.HOKANSON, INC.

Duns Number:071829634

Device Description: A battery powered remote timer used by a clinician to inflate and automatically deflate th A battery powered remote timer used by a clinician to inflate and automatically deflate the connected E20 Rapid Cuff Inflator.

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More Product Details

Catalog Number

01752

Brand Name

Hokanson

Version/Model Number

E20 3 Second Timer

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K905367

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

cf099b0d-fae6-4760-b083-1e40f6640d87

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