DVT-PRO

GUDID 18809315679845

Main device 1ea, CALF SLEEVE Medium [3CAGF10] 2ea, Tubing(81cm) 2ea [One set box]

DAESUNG MAREF CO.,LTD.

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• Primary Device ID: 18809315679845
• NIH Device Record Key: 06efc460-f09b-4d7a-9c15-6b2825e04481
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DVT-PRO
• Version Model Number: DVTP200-SC
• 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	08809315679848 [Primary]
GS1	18809315679845 [Package]; Contains: 08809315679848; 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: 2021-06-30
• Device Publish Date: 2021-06-22

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]