DEVICE: FUKUDA DENSHI (04538612912283)

Device Identifier (DI) Information

FUKUDA DENSHI
VS-2000
In Commercial Distribution

FUKUDA DENSHI CO.,LTD.
04538612912283
GS1

1
690671011 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Noninvasive multiple cardiovascular measurement unit An automated, mains electricity (AC-powered), portable electronic device designed to measure multiple cardiovascular parameters [including electrocardiogram (ECG), phonocardiogram (PCG), carotid pulse tracing, femoral pulse tracing and four limb pulse tracing/blood pressure] to assist in the diagnosis of cardiac and/or peripheral vascular disease. It typically consists of a control/analysis/display unit with cuffs, electrodes, audio and pressure sensors placed in strategic positions around the body. The device is typically operated by a healthcare professional.
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FDA Product Code

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Product Code Product Code Name
DXN System, Measurement, Blood-Pressure, Non-Invasive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K112521 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

436df7ff-51a6-4bd9-97ca-97e7688c89ef
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
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Customer Contact

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No Customer Contact currently defined
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