BELL-HORN

Basic Information

• Brand Name: BELL-HORN
• Primary DI: 00888912510653
• Version / Model: 99100XL
• Company Name: DJO, LLC
• Labeler DUNS: 081840873
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-27
• Public Version: 1
• Public Version Date: 2022-08-04
• Public Version Status: New
• Public Device Record Key: 33d966b2-787f-4ba7-802e-62e0986d65eb

Device Description

MASTECTOMY ARMSLEEVE 20-30MMHG, XL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
MHW	Dressing, compression	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30877	Single-chamber venous compression system garment, reusable	An inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent inflation of a single-chamber. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888912510653	GS1