SINGLE HOSE

GUDID 18809277421674

SINGLE HOSE for POWER-Q1000 PLUS

WONJIN MULSAN CO.LTD

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