4 chamber extension zipper

GUDID 18809802640662

CENTER BODY EXTENSION ZIPPER 2ea [One polybag]

DAESUNG MAREF CO.,LTD.

Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system

• Primary Device ID: 18809802640662
• NIH Device Record Key: 9bdf01a0-3be5-4063-872b-8eb9cde75f94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4 chamber extension zipper
• Version Model Number: 4ECGF01
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809802640665 [Primary]
GS1	18809802640662 [Package]; Contains: 08809802640665; Package: Box [5 Units]; In Commercial Distribution
GS1	28809802640669 [Package]; Contains: 08809802640665; Package: Box [10 Units]; In Commercial Distribution
GS1	38809802640666 [Package]; Contains: 08809802640665; Package: Box [20 Units]; In Commercial Distribution
GS1	48809802640663 [Package]; Contains: 08809802640665; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150033

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 [4 chamber extension zipper]

• 18809802640662: CENTER BODY EXTENSION ZIPPER 2ea [One polybag]
• 18809802640655: ARM EXTENSION ZIPPER 1ea [One polybag]
• 18809802640648: LEG EXTENSION ZIPPER XXLarge 2ea [One polybag]
• 18809802640631: LEG EXTENSION ZIPPER XLarge 2ea [One polybag]
• 18809802640624: LEG EXTENSION ZIPPER Large 2ea [One polybag]