DEVICE: VenoTrain micro (04046445918209)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Compression sock/stocking, single-use | A tube-like garment made of elastic material (e.g., circular knit nylon and Spandex yarns) that exerts a pressure across the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation [e.g., oedema, deep vein thrombosis (DVT), varicosis]. It may be intended to apply a graduated pressure across a limb, however it is not intended to support an injured joint. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
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DWL | Stocking, medical support (to prevent pooling of blood in legs) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K860826 | 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
962ae202-225b-49f7-9897-21d289c837e7
July 06, 2018
3
October 02, 2016
July 06, 2018
3
October 02, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined