DVT-SERIES

GUDID 18809315675397

Tubing (Single hose 3m), 2ea [One polybag]

DAESUNG MAREF CO.,LTD.

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 18809315675397
• NIH Device Record Key: e90e316c-4b48-418a-b461-fb2f66e4a1ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DVT-SERIES
• Version Model Number: DS301
• 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: true
• Serial Number: false
• 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	08809315675390 [Primary]
GS1	18809315675397 [Package]; Contains: 08809315675390; Package: box [5 Units]; In Commercial Distribution
GS1	28809315675394 [Package]; Contains: 08809315675390; Package: box [15 Units]; In Commercial Distribution
GS1	38809315675391 [Package]; Contains: 08809315675390; Package: Box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203016

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: 2021-06-29
• Device Publish Date: 2021-06-21

On-Brand Devices [DVT-SERIES]

• 18809315675700: SOFT CALF SLEEVE Small 2ea, [One polybag]
• 18809315675694: SOFT BOOT SLEEVE Medium 2ea, [One polybag]
• 18809315675540: NON-WOVEN THIGH SLEEVE X-Large 2ea, [One polybag]
• 18809315675533: NON-WOVEN THIGH SLEEVE Large 2ea, [One polybag]
• 18809315675526: NON-WOVEN THIGH SLEEVE Medium 2ea, [One polybag]
• 18809315675519: NON-WOVEN THIGH SLEEVE Small 2ea, [One polybag]
• 18809315675502: NON-WOVEN CALF SLEEVE X-Large 2ea, [One polybag]
• 18809315675496: NON-WOVEN CALF SLEEVE Large 2ea, [One polybag]
• 18809315675489: NON-WOVEN CALF SLEEVE Medium 2ea, [One polybag]
• 18809315675472: NON-WOVEN CALF SLEEVE Small 2ea, [One polybag]
• 18809315675465: NON-WOVEN BOOT SLEEVE Medium 2ea [One polybag]
• 18809315675458: NON-WOVEN FOOT SLEEVE, Medium 2ea [One polybag]
• 18809315675397: Tubing (Single hose 3m), 2ea [One polybag]
• 18809315675380: Tubing (Single hose 2.3m) ,2ea [One polybag]
• 18809315675373: MULTI-USE THIGH SLEEVE, Medium, 2ea [One polybag]
• 18809315675366: MULTI-USE CALF SLEEVE, Medium, 2ea [One polybag]
• 18809315675359: MULTI-USE BOOT SLEEVE, Medium, 2ea [One polybag]
• 18809315675342: MULTI-USE FOOT SLEEVE, Medium, 2ea [One polybag]
• 18809315675335: Tubing (Single hose 1.5m) 2ea [One polybag]
• 08809315675802: MULTI-USE FOOT SLEEVE (Medium [DS131] 2ea) MULTI-USE BOOT SLEEVE (Medium [DS141] 2ea) MULTI-USE
• 08809315675796: NON-WOVEN THIGH SLEEVE (Small [DS011] 2ea, Medium [DS012] 2ea, Large [DS013] 2ea, X-Large [DS01
• 08809315675789: SOFT CALF SLEEVE (Small [DS221] 2ea, Medium [DS222] 2ea, Large [DS223] 2ea, X-Large [DS224] 2ea
• 18809315675779: SOFT THIGH SLEEVE X-Large 2ea. [One polybag]
• 18809315675762: SOFT THIGH SLEEVE Large 2ea [One polybag]
• 18809315675755: SOFT THIGH SLEEVE Medium 2ea, [One polybag]
• 18809315675748: SOFT THIGH SLEEVE, Small 2ea, [One ploybag]
• 18809315675731: SOFT CALF SLEEVE X-Large 2ea, [One polybag]
• 18809315675724: SOFT CALF SLEEVE Large 2ea, [One polybag]
• 18809315675717: SOFT CALF SLEEVE, Medium 2ea, [One polybag]
• 18809802643946: NON-WOVEN FOOT SLEEVE, XLarge 2ea [One polybag]