FDA.reportPublic FDA data

ri-medic, Bluetooth®, wall mount, adult cuff and adult cuff obese, latex free

Primary DI
04045396201286
Brand
ri-medic, Bluetooth®, wall mount, adult cuff and adult cuff obese, latex free
Company
Rudolf Riester GmbH
Model
1785
Catalog number
1785
Device description
The ri-medic NIBP device is designed for the measurement and display of systolic and diastolic blood pressure and pulse rate.
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
K070750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070750000247 BP DEVICESuntech Medical, Inc.2007-05-02DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045396201286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045396201286040453962012864045396201286

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
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04045396006355Stethoscope duplex® de luxe neonatal,405240522021-01-28
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04045396006454Stethoscope tristar, blue, 3 chestpieces,409340932021-01-28
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04045396195387Stethoscope duplex® 2.0 white,4200-024200-022021-01-28
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