Compressible Limb Therapy System(MK300L)

Basic Information

• Brand Name: Compressible Limb Therapy System(MK300L)
• Primary DI: 08809315679138
• Version / Model: AC0634
• Company Name: DAESUNG MAREF CO.,LTD.
• Labeler DUNS: 688817949
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-10-24
• Public Version: 5
• Public Version Date: 2023-03-22
• Public Version Status: Update
• Public Device Record Key: 46f5363e-2709-4593-82e3-0e6974d9a2e5
• Distribution End Date: 2023-03-21

Device Description

6 chamber FULL BODY EXTENSION ZIPPER (One size)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: 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
IRP	Massager, Powered Inflatable Tube	Physical Medicine	890.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34489	Pneumatic massager	An pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.	No	Active
44768	Multi-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 sequential inflation of several chambers. 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
Package	28809315679132	GS1	BOX	20	Not in Commercial Distribution	2023-03-21
Primary	08809315679138	GS1
Package	18809315679135	GS1	BOX	10	Not in Commercial Distribution	2023-03-21
Unit of Use	08809315679121	GS1