Good Sense - Good Sense Automatic Arm Digital BP Unit - GEISS, DESTIN & DUNN, INC

Duns Number:076059836

Device Description: Good Sense Automatic Arm Digital BP Unit

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More Product Details

Catalog Number

-

Brand Name

Good Sense

Version/Model Number

69-550

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

-

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

3631baa3-01bc-47ee-b6d1-231ef5abe63b

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10846036007364

Quantity per Package

12

Contains DI Package

30846036007368

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON

"GEISS, DESTIN & DUNN, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 14