4 chamber sleeve

FDA UDI

Class II (US FDA UDI)

by Daesung Maref Co., Ltd.

Identity

Trade Name: 4 chamber sleeve FDA UDI
Generic Name: Intermittent venous compression system FDA UDI
Device Name: LEG SLEEVE Large 2ea, LEG SLEEVE XLarge 2ea, LEG SLEEVE XXLarge 2ea, ARM SLEEVE 1ea, WAIST SLEEVE 1ea, CENTER BODY SLEEVE 1ea, CENTER BODY EXTENSION ZIPPER 2ea [One Set Box] FDA UDI
Model / Reference: 4CHSET FDA UDI
Description: LEG SLEEVE Large 2ea, LEG SLEEVE XLarge 2ea, LEG SLEEVE XXLarge 2ea, ARM SLEEVE 1ea, WAIST SLEEVE 1ea, CENTER BODY SLEEVE 1ea, CENTER BODY EXTENSION ZIPPER 2ea [One Set Box] FDA UDI

Identifiers

Primary DI / UDI-DI: 08809802640368 FDA UDI
510(k) Number: K150033 FDA UDI
K202395 FDA UDI
K203498 FDA UDI
FDA Product Code: IRP FDA UDI
GMDN Term: Intermittent venous compression system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intermittent venous compression system

4 chamber sleeve by Daesung Maref Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Daesung Maref Co., Ltd.

Sources (1)

FDA UDI a706d761-706c-4cca-a291-a56de07aa9b7 34 fields · synced Jun 1, 2026