4 chamber sleeve

GUDID 18809802640501

OVERLAPPING LEG SLEEVE Small 1ea [One polybag]

DAESUNG MAREF CO.,LTD.

Intermittent venous compression system

• Primary Device ID: 18809802640501
• NIH Device Record Key: f96ade79-9ed6-4cfe-8e63-159ce8583bcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4 chamber sleeve
• Version Model Number: S401
• 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	08809802640504 [Primary]
GS1	18809802640501 [Package]; Contains: 08809802640504; Package: Box [6 Units]; In Commercial Distribution
GS1	28809802640508 [Package]; Contains: 08809802640504; Package: Box [10 Units]; In Commercial Distribution
GS1	38809802640505 [Package]; Contains: 08809802640504; Package: Box [20 Units]; In Commercial Distribution
GS1	48809802640502 [Package]; Contains: 08809802640504; Package: Box [30 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