Mueller Sports Medicine

FDA UDI

Class II (US FDA UDI)

by Mueller Sports Medicine, Inc.

Identity

Trade Name: Mueller Sports Medicine FDA UDI
Generic Name: Sequential venous compression system FDA UDI
Device Name: M4 Gear Pack MD FDA UDI
Model / Reference: M4RG200MD FDA UDI
Description: M4 Gear Pack MD FDA UDI

Identifiers

Catalog Number: M4RG200MD FDA UDI
Primary DI / UDI-DI: 00074676006864 FDA UDI
510(k) Number: K190493 FDA UDI
FDA Product Code: IRP FDA UDI
GMDN Term: Sequential 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sequential venous compression system

Mueller Sports Medicine by Mueller Sports Medicine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K190493 also covers:

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: Mueller Sports Medicine, Inc.

Sources (1)

FDA UDI 8e17cdcc-718c-49fc-8067-2b2ac10403cd 37 fields · synced Jun 9, 2026