FDA.report

ri-champion® smartPRO Blutdruckmessgerät mit M-Manschette

Primary DI
04045396218918
Brand
ri-champion® smartPRO Blutdruckmessgerät mit M-Manschette
Company
Rudolf Riester GmbH
Model
1735
Catalog number
1735
Device description
ri-champion® N is a non-invasive blood pressure monitors for measuring at the upper arm
Published
2021-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications

CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04045396218918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04045396218918040453962189184045396218918

GMDN Terms

TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.

Sterilization Methods

Method

Regulatory Flags

DUNS number
537208717
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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