Compressible Limb Therapy System

GUDID 28809315678357

Sequential compression pump with 1 double hose

DAESUNG MAREF CO.,LTD.

Pneumatic massager

• Primary Device ID: 28809315678357
• NIH Device Record Key: 15077091-44a1-4f9e-8c65-33e7319ec942
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compressible Limb Therapy System
• Version Model Number: LX7(V7)
• Company DUNS: 688817949
• Company Name: DAESUNG MAREF CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18809315678350 [Primary]
GS1	28809315678357 [Package]; Contains: 18809315678350; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102320

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-20
• Device Publish Date: 2018-06-19

On-Brand Devices [Compressible Limb Therapy System]

• 18809315678985: Compressible Limb Therapy System pump with 1arm sleeve, 2extension zipper and 4single hoses.
• 18809315678978: Compressible Limb Therapy System pump with 2leg sleeves(Extra large), 1waist sleeve, 1arm sleeve
• 18809315678961: Compressible Limb Therapy System pump with 2leg sleeves(Large), 1waist sleeve, 1arm sleeve and 4
• 28809315678944: LX7 set : Sequential Compression Pump with 2 Leg Sleeves(XXL Size), 1 Double Hose
• 28809315678937: LX7 set : Sequential Compression Pump with 2 Leg Sleeves(XL Size), 1 Double Hose
• 28809315678920: LX7 set : Sequential Compression Pump with 2 Leg Sleeves(L Size), 1 Double Hose
• 28809315678364: Sequential compression pump with 1 double hose and 1 single hose.
• 28809315678357: Sequential compression pump with 1 double hose
• 28809315678159: Sequential compression pump with 2 leg sleeve (M), 1 double hose and 1 single hose.
• 28809315677824: Sequential compression pump with 2 leg sleeve (XL), 1 double hose and 1 single hose.
• 18809315677810: Sequential compression pump with 2 leg sleeve (L), 1 double hose and 1 single hose.
• 08809315678957: Sequential compression pump only.