AeroDVx™, Small Flex Bilateral

FDA UDI

Class II (US FDA UDI)

by Sun-Scientific Inc.

Identity

Trade Name: AeroDVx™, Small Flex Bilateral FDA UDI
Generic Name: Intermittent venous compression system pump FDA UDI
Device Name: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pneumatic pump and hand pump to provide static and/or intermittent pneumatic compression for compression therapy or DVT Prophylaxis. The Bilateral system contains two sleeves. The AeroDVx™ gradient compression sleeve is a non-sterile single patient use medical device. The AeroDVx™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg, and attached and unattached sock. An inflation source is attached to the inflation valve on the sleeve. There are two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, to provide intermittent pneumatic compression and a hand pump to provide static compression. The system is intended for hospital and outpatient use. FDA UDI
Model / Reference: Small Flex Bilateral FDA UDI
Description: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pneumatic pump and hand pump to provide static and/or intermittent pneumatic compression for compression therapy or DVT Prophylaxis. The Bilateral system contains two sleeves. The AeroDVx™ gradient compression sleeve is a non-sterile single patient use medical device. The AeroDVx™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg, and attached and unattached sock. An inflation source is attached to the inflation valve on the sleeve. There are two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, to provide intermittent pneumatic compression and a hand pump to provide static compression. The system is intended for hospital and outpatient use. FDA UDI

Identifiers

Catalog Number: DV-BSF FDA UDI
Primary DI / UDI-DI: 00856525007792 FDA UDI
510(k) Number: K183349 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Intermittent venous compression system pump

AeroDVx™, Small Flex Bilateral by Sun-Scientific Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K183349 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: Sun-Scientific Inc.

Sources (1)

FDA UDI 1f641e3e-02a8-486c-abd8-d496cddb3c9a 36 fields · synced Jun 1, 2026