minimus® III, adult size velcro cuff - Aneroid sphygmomanometers for non invasive - Rudolf Riester GmbH

Duns Number:537208717

Device Description: Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure.

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More Product Details

Catalog Number

1342

Brand Name

minimus® III, adult size velcro cuff

Version/Model Number

1342

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

K942649

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

32a53012-0278-4a9a-96ad-eaa37f801756

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RUDOLF RIESTER GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 282
2 A medical device with a moderate to high risk that requires special controls. 332