The Venous Assist System

GUDID 28809315677732

1 Chamber foot garment(One size)

DAESUNG MAREF CO.,LTD.

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• Primary Device ID: 28809315677732
• NIH Device Record Key: 5b903eb6-9ffd-4287-8621-4fe5b1623247
• Commercial Distribution Discontinuation: 2021-06-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Venous Assist System
• Version Model Number: DS032
• Company DUNS: 688817949
• Company Name: DAESUNG MAREF CO.,LTD.
• Device Count: 2
• 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: true
• 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	08809315677721 [Unit of Use]
GS1	08809315677738 [Primary]
GS1	18809315677735 [Package]; Contains: 08809315677738; Package: Box [20 Units]; Discontinued: 2021-06-30; In Commercial Distribution
GS1	28809315677732 [Package]; Contains: 08809315677738; Package: Box [120 Units]; Discontinued: 2021-06-30; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150980

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-06-23
• Device Publish Date: 2016-09-06

On-Brand Devices [The Venous Assist System]

• 28809315678395: sequential compression pump with 2 hoses
• 28809315677695: Sequential compression pump with 2 Calf sleeves, 2 Hoses and Extension hoses
• 28809315677732: 1 Chamber foot garment(One size)
• 08809315678384: Sequential compression pump only
• 28809315677756: Calf garment extension pad
• 28809315677718: 3 Chamber calf garment(One size)
• 08809315677684: Sequential compression pump only, The DVT-PRO device is a specialized intermittent pneumatic com