JOBST Bella

Basic Information

• Brand Name: JOBST Bella
• Primary DI: 00035664025830
• Version / Model: 7529147
• Catalog Number: 7529147
• Company Name: BSN MEDICAL, INC.
• Labeler DUNS: 026301221
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-21
• Public Version: 5
• Public Version Date: 2022-05-20
• Public Version Status: Update
• Public Device Record Key: 28521163-7ee4-432f-8847-2494320a1e2b

Device Description

BELLA STRONG 20-30 MM HG GLOVES SIZE 8 BEIGE 1

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MDR	BINDER, MEDICAL, THERAPEUTIC	General Hospital	880.5160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30878	Compression/pressure sock/stocking, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00035664026431	GS1		10	In Commercial Distribution
Primary	00035664025830	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20-30 mmHg