The Venous Assist System(DVT-2600)

GUDID 38809315678453

3chamber non-woven thigh garment (Large size)

DAESUNG MAREF CO.,LTD.

Multi-chamber venous compression system garment, single-use

• Primary Device ID: 38809315678453
• NIH Device Record Key: 7e7bf2d2-9939-465e-9fda-4d114cdda5fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Venous Assist System(DVT-2600)
• Version Model Number: DS013
• 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	08809315678445 [Unit of Use]
GS1	08809315678452 [Primary]
GS1	18809315678459 [Package]; Contains: 08809315678452; Package: BOX [10 Units]; In Commercial Distribution
GS1	28809315678456 [Package]; Contains: 18809315678459; Package: BOX [2 Units]; In Commercial Distribution
GS1	38809315678453 [Package]; Contains: 18809315678459; Package: BOX [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112677

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: 2021-06-24
• Device Publish Date: 2016-10-18

On-Brand Devices [The Venous Assist System(DVT-2600)]

• 38809315678835: 3chamber oxford boots garment (One size)
• 08809315678490: 3chamber non-woven calf garment (Small size)
• 38809315678811: 1chamber oxford foot garment (One size)
• 38809315678774: 3chamber oxford thigh garment (One size)
• 38809315678712: 3chamber soft fabric calf garment (Extra large size)
• 38809315678651: 3chamber soft fabric calf garment (Small size)
• 38809315678910: 3chamber non-woven boots garment (One size)
• 38809315678798: 3chamber oxford calf garment (One size)
• 38809315678750: 3chamber soft fabric boots garment (One size)
• 38809315678736: 1chamber lylex foot garment (One size)
• 38809315678699: 3chamber soft fabric calf garment (Large size)
• 38809315678637: 3chamber soft fabric thigh garment (Extra large size)
• 38809315678613: 3chamber soft fabric thigh garment (Large size)
• 38809315678590: 3chamber soft fabric thigh garment (Medium size)
• 38809315678576: 3chamber soft fabric thigh garment (Small size)
• 38809315678538: 3chamber non-woven calf garment (Large size)
• 08809315678513: 3chamber non-woven calf garment (Medium size)
• 38809315678477: 3chamber non-woven thigh garment (Extra large size)
• 38809315678453: 3chamber non-woven thigh garment (Large size)
• 38809315678439: 3chamber non-woven thigh garment (Medium size)
• 08809315678414: 3chamber non-woven thigh garment (Small size)