AccessGUDID - DEVICE: VenoTrain micro (04046445918209)

GUDID

Device Identifier (DI) Information

Brand Name: VenoTrain micro
Version or Model: 21860517520332
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bauerfeind AG

Primary DI Number: 04046445918209
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315914853 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
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.

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

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Product Code	Product Code Name
DWL	Stocking, medical support (to prevent pooling of blood in legs)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K860826	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 962ae202-225b-49f7-9897-21d289c837e7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 02, 2016