AccessGUDID - DEVICE: JOBST Elvarex (04059993063406)

GUDID

Device Identifier (DI) Information

Brand Name: JOBST Elvarex
Version or Model: 77559-00153-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BSN-Jobst GmbH

Primary DI Number: 04059993063406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315917492 *Terms of Use

Device Description: ELVAREX 2/ARM SLEEVE FROM WRIST TO AXILLA WITH BIAS TOP END/DOTTED 2,5 CM SILICONE BAND ON TOP/CHERRY

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42811	Compression/pressure sock/stocking, reusable	A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a reusable device.	Active	false

FDA Product Code

[?]

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: 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
Device Size Text, specify: Pressure 23-32 mmHg

Device Record Status

Public Device Record Key: 6024e8f5-5b6a-4c54-83b9-b87969090220
Public Version Date: December 08, 2020
Public Version Number: 1
DI Record Publish Date: November 30, 2020