4 chamber sleeve

GUDID 18809802640570

OVERLAPPING LEG SLEEVE Large Wide 1ea [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: 18809802640570
• NIH Device Record Key: 521a2b76-7ee7-4a40-ab53-2b2b0cdd0a48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4 chamber sleeve
• Version Model Number: LW401
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809802640573 [Primary]
GS1	18809802640570 [Package]; Contains: 08809802640573; Package: Box [4 Units]; In Commercial Distribution
GS1	28809802640577 [Package]; Contains: 08809802640573; Package: Box [6 Units]; In Commercial Distribution
GS1	38809802640574 [Package]; Contains: 08809802640573; Package: Box [20 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 sleeve]

• 18809802640617: OVERLAPPING ARM SLEEVE Large 1ea [One polybag]
• 18809802640600: OVERLAPPING ARM SLEEVE Medium 1ea [One polybag]
• 18809802640594: OVERLAPPING HALF-LEG SLEEVE Medium Wide 1ea [One polybag]
• 18809802640587: OVERLAPPING HALF-LEG SLEEVE Medium 1ea [One polybag]
• 18809802640570: OVERLAPPING LEG SLEEVE Large Wide 1ea [One polybag]
• 18809802640563: OVERLAPPING LEG SLEEVE Large 1ea [One polybag]
• 18809802640556: OVERLAPPING LEG SLEEVE Medium X-Wide 1ea [One polybag]
• 18809802640549: OVERLAPPING LEG SLEEVE Medium Wide 1ea [One polybag]
• 18809802640532: OVERLAPPING LEG SLEEVE Medium 1ea [One polybag]
• 18809802640525: OVERLAPPING LEG SLEEVE Small X-Wide 1ea [One polybag]
• 18809802640518: OVERLAPPING LEG SLEEVE Small Wide 1ea [One polybag]
• 18809802640501: OVERLAPPING LEG SLEEVE Small 1ea [One polybag]
• 18809802640495: OVERLAPPING ARM CHEST 1ea, Strap 10*40 2ea, 5*40 1ea, 10*80 2ea, 5*80 1ea [One Set Box]
• 18809802640433: STRETCHING MAT 4 1ea [One Set Box]
• 18809802640426: CENTER BODY SLEEVE 1ea [One polybag]
• 18809802640419: WAIST SLEEVE 1ea [One polybag]
• 18809802640396: LEG SLEEVE XXLarge 1ea [One polybag]
• 18809802640389: LEG SLEEVE XLarge 1ea [One polybag]
• 18809802640372: LEG SLEEVE Large 1ea [One polybag]
• 18809802640402: ARM SLEEVE 1ea [One polybag]
• 08809802640368: LEG SLEEVE Large 2ea, LEG SLEEVE XLarge 2ea, LEG SLEEVE XXLarge 2ea, ARM SLEEVE 1ea, WAIST SLEEV