DVT-PRO

GUDID 18809802644455

Main device 1ea, Tubing (81cm) 2ea, Tubing (102cm) 2ea [One set box]

DAESUNG MAREF CO.,LTD.

Sequential venous compression system

• Primary Device ID: 18809802644455
• NIH Device Record Key: 900c7653-b416-450c-b3fb-317e21266cd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DVT-PRO
• Version Model Number: DVTP200-2
• 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: true
• 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	08809802644458 [Primary]
GS1	18809802644455 [Package]; Contains: 08809802644458; Package: Box [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203353

FDA Product Code

• JOW: Sleeve, Limb, Compressible

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: 2023-12-19
• Device Publish Date: 2023-12-11

On-Brand Devices [DVT-PRO]

• 18809315679906: Tubing (102cm) [DS310] 1ea [One polybag]
• 18809315679890: Tubing(81cm) [DS311] 1ea [One polybag]
• 18809315679883: EXTENSION_PAD Medium [DS500] 2ea [One polybag]
• 18809315679876: MULTI-USE THIGH SLEEVE Medium [3CAUF10] 2ea [One poly bag]
• 18809315679869: CALF SLEEVE Medium [3CAGF10] 2ea [One polybag]
• 08809315679855: Main device 1ea, MULTI-USE THIGH SLEEVE Medium[3CAUF10] 2ea, Tubing(81cm) 2ea [One set box]
• 18809315679845: Main device 1ea, CALF SLEEVE Medium [3CAGF10] 2ea, Tubing(81cm) 2ea [One set box]
• 18809315679838: Main device 1ea, Tubing (81cm) 2ea [One set box]
• 08809315679824: Main device 1ea
• 18809802644455: Main device 1ea, Tubing (81cm) 2ea, Tubing (102cm) 2ea [One set box]