Aero-Wrap™ Bilateral Kit, Extra Large

FDA UDI

Class I (US FDA UDI)

by Sun-Scientific Inc.

Identity

Trade Name: Aero-Wrap™ Bilateral Kit, Extra Large FDA UDI
Generic Name: Sequential venous compression system FDA UDI
Device Name: The AeroWrap ™ Bilateral Kit System is comprised of two gradient compression sleeves, and a hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ kit system gradient compression sleeves are non-sterile single patient use medical device. The AeroWrap™ Bilateral Kit Gradient Compression Sleeves contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s legs from the ankle to the knee. An inflation source is attached to the inflation valve on the sleeve. There is a inflation source provided: a hand pump to provide static compression. The system is intended for hospital and outpatient use. FDA UDI
Model / Reference: AW6580-03 FDA UDI
Description: The AeroWrap ™ Bilateral Kit System is comprised of two gradient compression sleeves, and a hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ kit system gradient compression sleeves are non-sterile single patient use medical device. The AeroWrap™ Bilateral Kit Gradient Compression Sleeves contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s legs from the ankle to the knee. An inflation source is attached to the inflation valve on the sleeve. There is a inflation source provided: a hand pump to provide static compression. The system is intended for hospital and outpatient use. FDA UDI

Identifiers

Catalog Number: AWB-LLBX FDA UDI
Primary DI / UDI-DI: 00856525007556 FDA UDI
510(k) Number: K070457 FDA UDI
FDA Product Code: MHW FDA UDI
GMDN Term: Sequential venous compression system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5075 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

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

FDA UDI

Category: Sequential venous compression system

Aero-Wrap™ Bilateral Kit, Extra Large by Sun-Scientific Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Sun-Scientific Inc.

Sources (1)

FDA UDI 8186edc1-5436-4005-9c8b-f31be50da31b 37 fields · synced May 29, 2026