FDA.reportPublic FDA data

ri-champion® N, Pull through strap velcro cuff adult obese size, latex free

Primary DI
04045396211872
Brand
ri-champion® N, Pull through strap velcro cuff adult obese size, latex free
Company
Rudolf Riester GmbH
Model
1725-146
Catalog number
1725-146
Device description
ri-champion® N is a non-invasive blood pressure monitors for measuring at the upper arm
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013485000MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1Microlife Corp.2002-01-17DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045396211872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045396211872040453962118724045396211872

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
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04045396000186Stethoscope cardiophon 2.0, burgundy4240-044240-042021-01-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911645N/AShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911652ANOVATORShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911669SPASTACISEShenzhen Urion Technology Co., LtdDXN2026-07-24
06932825306057CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
06932825306064CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
00073796318321WIDE-RANGE D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00816042016516FORAFORA CARE INC.DXN2026-07-20
00898939002758FORAFORA CARE INC.DXN2026-07-20
06953825911515N/AShenzhen Urion Technology Co., LtdDXN2026-07-16
00850044118670iHealthiHealth Labs Inc.DXN2026-07-14
00850044118687iHealthiHealth Labs Inc.DXN2026-07-14
00850078377234iHealthiHealth Labs Inc.DXN2026-07-14
06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13
00845717011556N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
00845717011563N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040112842N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040113481N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114358N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114365N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040117397N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
MHC18602130N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06953825911294N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911300N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911317AlphamedShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911355N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911393N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07