CERAGEM Master V9

Basic Information

• Brand Name: CERAGEM Master V9
• Primary DI: 08809643652087
• Version / Model: CGM MB-2401
• Company Name: CERAGEM Co., Ltd.
• Labeler DUNS: 688326136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-15
• Public Version: 1
• Public Version Date: 2025-07-23
• Public Version Status: New
• Public Device Record Key: 2f0cfaf6-3465-4a38-8dc8-6c8086ecf9f6

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
JFB	Table, Physical Therapy, Multi Function	Physical Medicine	890.5880	2
IRP	Massager, Powered Inflatable Tube	Physical Medicine	890.5650	2
IRO	Vibrator, Therapeutic	Physical Medicine	890.5975	1
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32264	Massage table/couch, line-powered	A mains electricity (AC-powered) table designed for various kinds of complementary therapy (e.g., massage, acupuncture, aromatherapy, reflexology, kinesiology). It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table is electrically adjusted. It may incorporate a face hole (the patient's face fits into this when lying prone), a headrest, and an armrest(s). This device is typically known as a massage/therapy table, couch or bed.	No	Active
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.	No	Active
44785	Sequential venous compression system inflator	An electrically-powered device intended to be used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, it typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809643652087	GS1