AccessGUDID - DEVICE: JOBST forMen Casual (00035664005580)

GUDID

Device Identifier (DI) Information

Brand Name: JOBST forMen Casual
Version or Model: 113152
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 113152
Company Name: BSN MEDICAL, INC.

Primary DI Number: 00035664005580
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 026301221 *Terms of Use

Device Description: FOR MEN CASUAL 15-20 MM HG KNEE HIGH CLOSED TOE LARGE FULL CALF NAVY 1 EN FR ES

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):	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Device Size Text, specify: 15-20 mmHg

Device Record Status

Public Device Record Key: b3473465-b8a2-4865-8168-79fa51c3a383
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 08, 2016