DEVICE: MEDI (00636257189085)
Device Identifier (DI) Information
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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58928 | Noninvasive ankle brachial pressure index measurement unit |
An automated, battery-powered, portable electronic device designed to calculate the ankle brachial pressure index (ABPI), used in the diagnosis of peripheral vascular disease (PVD), from simultaneous oscillometric measurement of the ankle and brachial blood pressure indices. It typically consists of a control/analysis/display unit with cuffs placed around an arm and one or both ankles; it uses integrated transducers to measure cuff pressure oscillations which represent the fluctuations of pressure in the underlying blood vessels. The device is typically operated by a healthcare professional.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JOM | PLETHYSMOGRAPH, PHOTOELECTRIC, PNEUMATIC OR HYDRAULIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
d488db45-b03c-45d5-861a-740500fdea64
April 29, 2020
2
November 20, 2018
April 29, 2020
2
November 20, 2018
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
[?]
+1(800)633-6334
info@mediusa.com
info@mediusa.com