JOBST Elvarex Plus

Basic Information

• Brand Name: JOBST Elvarex Plus
• Primary DI: 04059993700806
• Version / Model: 79541-00020-00
• Catalog Number: 79541-00020-00
• Company Name: BSN-Jobst GmbH
• Labeler DUNS: 315917492
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-18
• Public Version: 2
• Public Version Date: 2024-01-19
• Public Version Status: Update
• Public Device Record Key: 5883a6f0-e210-4497-845a-10ef3c6be33f

Device Description

ELVAREX PLUS 2/GLOVE/WITH FINGER, WITH THUMB/BEIGE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWL	Stocking, medical support (to prevent pooling of blood in legs)	General Hospital	880.5780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16500	Compression/pressure glove	A device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04059993700806	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123561	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Pressure 23-32 mmHg