SP-2000

GUDID 18809315672389

Main device 1ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One set box]

DAESUNG MAREF CO.,LTD.

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• Primary Device ID: 18809315672389
• NIH Device Record Key: f009c1c1-b187-483d-9f54-81eb284e8dd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SP-2000
• Version Model Number: SP20200-AS
• 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	08809315672382 [Primary]
GS1	18809315672389 [Package]; Contains: 08809315672382; Package: Box [2 Units]; In Commercial Distribution

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: 2021-12-27
• Device Publish Date: 2021-12-17

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