SP-2000

GUDID 08809802645493

Main Device 1ea, Leg Sleeve (L) 2ea, Double Tubing 1ea, Recovery Bag 1ea [One Set Box]

DAESUNG MAREF CO.,LTD.

Sequential venous compression system inflator

• Primary Device ID: 08809802645493
• NIH Device Record Key: c312a13e-47e2-4fbe-85a2-81a1cc691f51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SP-2000
• Version Model Number: SP20100-RL
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809802645493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202395

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [SP-2000]

• 18809315672419: Main device 1ea, LEG SLEEVE XXLarge 2ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One s
• 18809315672402: Main device 1ea, LEG SLEEVE XLarge 2ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One se
• 18809315672396: Main device 1ea, LEG SLEEVE Large 2ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One set
• 18809315672389: Main device 1ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One set box]
• 18809315672372: Main device 1ea, CENTER BODY SLEEVE 1ea, CENTER BODY EXTENSION ZIPPER 2ea, Double Hose 1ea [One
• 18809315672303: Main device 1ea, LEG SLEEVE XXLarge 2ea, Single Hose 1ea, Double Hose 1ea [One set box]
• 18809315672297: Main device 1ea, LEG SLEEVE XLarge 2ea, Single Hose 1ea, Double Hose 1ea [One set box]
• 18809315672280: Main device 1ea, LEG SLEEVE Large 2ea, Single Hose 1ea, Double Hose 1ea [One set box]
• 18809315672273: Main device 1ea, LEG SLEEVE XXLarge 2ea, Double Hose 1ea [One set box]
• 18809315672266: Main device 1ea, LEG SLEEVE XLarge 2ea, Double Hose 1ea [One set box]
• 18809315672259: Main device 1ea, LEG SLEEVE Large 2ea, Double Hose 1ea [One set box]
• 08809315672245: Main device 1ea
• 08809802645516: Main Device 1ea, Leg Sleeve (XXL) 2ea, Double Tubing 1ea, Recovery Bag 1ea [One Set Box]
• 08809802645509: Main Device 1ea, Leg Sleeve (XL) 2ea, Double Tubing 1ea, Recovery Bag 1ea [One Set Box]
• 08809802645493: Main Device 1ea, Leg Sleeve (L) 2ea, Double Tubing 1ea, Recovery Bag 1ea [One Set Box]
• 18809802645483: Main Device 1ea, Leg Sleeve (XXL) 2ea, Double Tubing 1ea [One Set Box]
• 18809802645476: Main Device 1ea, Leg Sleeve (XL) 2ea, Double Tubing 1ea [One Set Box]
• 18809802645469: Main Device 1ea, Leg Sleeve (L) 2ea, Double Tubing 1ea [One Set Box]
• 08809802645455: Main Device 1ea