DEVICE: diplomat-presameter® desk, light grey, adult size bandage cuff (04045396001275)
Device Identifier (DI) Information
diplomat-presameter® desk, light grey, adult size bandage cuff
1000
In Commercial Distribution
1000
Rudolf Riester GmbH
1000
In Commercial Distribution
1000
Rudolf Riester GmbH
Mercury sphygmomanometers for non invasive measurement of arterial blood pressure.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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16158 | Mercury manual sphygmomanometer |
A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, a mercury manometer, and tubing. The mercury manometer consists of a reservoir containing mercury (Hg) and a graduated column in which the mercury rises and falls in response to pressure in the cuff. The manometer may be mounted to a wall or placed on a table and is considered the gold standard for measuring blood pressure because it remains calibrated; blood pressure measurement is taken in conjunction with a stethoscope.
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FDA Product Code
[?]Product Code | Product Code Name |
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DXN | System, Measurement, Blood-Pressure, Non-Invasive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K943461 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9c0f3e52-da46-45bf-b840-a2b46304e8f3
July 06, 2018
3
August 29, 2016
July 06, 2018
3
August 29, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined