EXTENSION ZIPPER

GUDID 38809277423214

EXTENSION ZIPPER for POWER Q1000 PREMIUM

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 Sequential venous compression system pump

• Primary Device ID: 38809277423214
• NIH Device Record Key: 1bb3161b-b7b9-4f86-b9eb-73469ea22bcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXTENSION ZIPPER
• Version Model Number: POWER-Q1000PREMIUM
• 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	08809277423213 [Primary]
GS1	18809277423210 [Package]; Contains: 08809277423213; Package: [10 Units]; In Commercial Distribution
GS1	28809277423217 [Package]; Contains: 08809277423213; Package: [20 Units]; In Commercial Distribution
GS1	38809277423214 [Package]; Contains: 08809277423213; Package: [30 Units]; In Commercial Distribution
GS1	48809277423211 [Package]; Contains: 08809277423213; Package: [40 Units]; In Commercial Distribution
GS1	58809277423218 [Package]; Contains: 08809277423213; Package: [50 Units]; In Commercial Distribution
GS1	88809277423219 [Package]; Contains: 08809277423213; Package: [80 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: 6
• Public Version Date: 2020-01-21
• Device Publish Date: 2019-03-04

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: 2020-01-21EXTENSION ZIPPER for POWER Q1000 PREMIUM
• 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