Compressible Limb Therapy System(Lympha-Flow(LF400

GUDID 38809315678309

4 Chamber Overlapping Half-leg (Medium) sleeve with Hose

DAESUNG MAREF CO.,LTD.

Pneumatic massager

• Primary Device ID: 38809315678309
• NIH Device Record Key: 27c90560-2e9a-4cf3-8ed0-9c81cb31ebff
• Commercial Distribution Discontinuation: 2017-12-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Compressible Limb Therapy System(Lympha-Flow(LF400
• Version Model Number: ACg0470
• 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: true
• Serial Number: false
• 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	38809315678309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150033

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-11

On-Brand Devices [Compressible Limb Therapy System(Lympha-Flow(LF400]

• 48809315678313: 4 Chamber Overlapping Half-leg (Medium Wide) sleeve with Hose
• 48809315678306: 4 Chamber Overlapping Half-leg (Medium) sleeve with Hose
• 38809315678316: 4 Chamber Overlapping Half-leg (Medium Wide) sleeve with Hose
• 38809315678309: 4 Chamber Overlapping Half-leg (Medium) sleeve with Hose