WONJIN

GUDID 18809277423470

Sequential venous compressiion system pump, a power inflatable tube massager

WONJIN MULSAN CO.LTD

Sequential venous compression system pump

• Primary Device ID: 18809277423470
• NIH Device Record Key: 54579ee2-58cf-43f3-bc6c-7f34f3bd3502
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WONJIN
• Version Model Number: POWER-Q2300
• Company DUNS: 690287912
• Company Name: WONJIN MULSAN 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: false
• Expiration Date: false
• Donation Id Number: false
• 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	08809277423466 [Primary]
GS1	18809277423470 [Package]; Contains: 08809277423466; Package: [1 Units]; In Commercial Distribution
GS1	28809277423477 [Package]; Package: [2 Units]; In Commercial Distribution
GS1	38809277423474 [Package]; Package: [3 Units]; In Commercial Distribution
GS1	48809277423471 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100656

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: 2022-01-19
• Device Publish Date: 2022-01-11

Devices Manufactured by WONJIN MULSAN CO.LTD

• 18809277423470 - WONJIN: 2022-01-19Sequential venous compressiion system pump, a power inflatable tube massager
• 18809277423470 - WONJIN: 2022-01-19 Sequential venous compressiion system pump, a power inflatable tube massager
• 08809277420014 - POWER-Q1000: 2022-01-04 Sequential venous compression system pump, A powered inflatable tube massager
• 38809277423214 - EXTENSION ZIPPER: 2020-01-21 EXTENSION ZIPPER for POWER Q1000 PREMIUM
• 18809277421674 - SINGLE HOSE: 2019-07-23 SINGLE HOSE for POWER-Q1000 PLUS
• 08809277420885 - POWER-Q1000PLUS: 2019-04-25 Sequential venous compression system pump, A power inflatable tube massager
• 38809277420442 - POWER-Q1000PREMIUM: 2018-07-06 Sequential venous compression system pump, A powered inflatable tube massager
• 48809277426021 - POWER-Q1000: 2018-07-06 Sequential venous compression system pump, A powered inflatable tube massager