DVT-PRO

GUDID 18809802644455

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

DAESUNG MAREF CO.,LTD.

Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system 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]