SINGLE HOSE

GUDID 18809277421674

SINGLE HOSE for POWER-Q1000 PLUS

WONJIN MULSAN CO.LTD

Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump

• Primary Device ID: 18809277421674
• NIH Device Record Key: b88e3093-3f2a-4fdc-87de-03adbbca094d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINGLE HOSE
• Version Model Number: WHF-324
• 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: false
• 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	08809277421677 [Primary]
GS1	18809277421674 [Package]; Contains: 08809277421677; Package: [10 Units]; In Commercial Distribution
GS1	28809277421671 [Package]; Contains: 08809277421677; Package: [20 Units]; Discontinued: 2019-07-23; Not in Commercial Distribution
GS1	38809277421678 [Package]; Contains: 08809277421677; Package: [30 Units]; Discontinued: 2019-07-23; Not in Commercial Distribution
GS1	48809277421675 [Package]; Contains: 08809277421677; Package: [40 Units]; Discontinued: 2019-07-23; Not in Commercial Distribution
GS1	58809277421672 [Package]; Contains: 08809277421677; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113275

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-04-18

Devices Manufactured by WONJIN MULSAN CO.LTD

• 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: 2019-07-23SINGLE HOSE for POWER-Q1000 PLUS
• 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