FDA.reportPublic FDA data

RVS-100

Primary DI
04045396216327
Brand
RVS-100
Company
Rudolf Riester GmbH
Model
1960-RRXXU
Catalog number
1960-RRXXU
Device description
Vital Sign Monitoring
Published
2019-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170538000RVS-100 Vital Signs MonitorRudolf Riester GmbH2017-10-17MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045396216327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045396216327040453962163274045396216327

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
537208717
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04045396006317Stethoscope duplex® baby, blue, aluminium,404140412021-01-28
04045396006324Stethoscope duplex® de luxe baby, blue,404240422021-01-28
04045396006348Stethoscope duplex® neonatal, blue, aluminium,405140512021-01-28
04045396006355Stethoscope duplex® de luxe neonatal,405240522021-01-28
04045396006430Stethoscope tristar, slate-grey, 3 chestpieces,409140912021-01-28
04045396006454Stethoscope tristar, blue, 3 chestpieces,409340932021-01-28
04045396118485Stethoscope duplex®, black, aluminium,4001-014001-012021-01-28
04045396118492Stethoscope duplex®, slate grey, aluminium,4001-024001-022021-01-28
04045396118683Teaching stethoscope duplex®, slate-grey,4002-024002-022021-01-28
04045396118867Stethoscope duplex®, blue, aluminium,4031-034031-032021-01-28
04045396119826Stethoscope anestophon, slate-grey, aluminium,4177-024177-022021-01-28
04045396119833Stethoscope anestophon, blue, aluminium,4177-034177-032021-01-28
04045396119857Stethoscope anestophon, green, aluminium,4177-054177-052021-01-28
04045396163546Stethoscope duplex® 2.0 blue,4210-034210-032021-01-28
04045396177390Stethoscope duplex® 2.0 baby, black,4220-014220-012021-01-28
04045396177406Stethoscope duplex® 2.0 neonatal, black4230-014230-012021-01-28
04045396195370Stethoscope duplex® 2.0 black4200-014200-012021-01-28
04045396195387Stethoscope duplex® 2.0 white,4200-024200-022021-01-28
04045396195394Stethoscope duplex® 2.0 blue,4200-034200-032021-01-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04255629200973NIBP Pressure cuff 14 - 21,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200980NIBP Pressure cuff 20,5 - 28,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
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