Microtek

FDA UDI

Class II (US FDA UDI)

by Microtek Medical LLC

Identity

Trade Name: MICROTEK FDA UDI
Generic Name: Intermittent venous compression system pump FDA UDI
Device Name: VENODYNE COMPRESSION SYSTEM 610-230, 1-CASE FDA UDI
Model / Reference: 1 FDA UDI
Description: VENODYNE COMPRESSION SYSTEM 610-230, 1-CASE FDA UDI

Identifiers

Primary DI / UDI-DI: 50748426065030 FDA UDI
510(k) Number: K001802 FDA UDI
FDA Product Code: JOW FDA UDI
GMDN Term: Intermittent venous compression system pump FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5800 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Intermittent venous compression system pump

Microtek by Microtek Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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AeroDVx ™ — SUN-SCIENTIFIC INC. · Class II
Entre — TACTILE SYSTEMS TECHNOLOGY INC · Class II

Cleared under the same submission

K001802 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: Microtek Medical LLC

Sources (1)

FDA UDI 27d4ffa2-6ef0-41af-b4da-8c27ed5eced1 36 fields · synced Jun 8, 2026