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AeroWrap™ Full Leg

FDA UDI

Class I (US FDA UDI)

by Sun-Scientific Inc.

Identity

Trade Name
AeroWrap™ Full Leg FDA UDI
Generic Name
Multi-chamber venous compression system garment, single-use FDA UDI
Device Name
The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the knee a Thigh sleeve from the knee to the crotch, a compression knee wrap, and a foot compression wrap. A hand pump is included to provide static compression for compression therapy. The AeroWrap™ Full Leg gradient compression system sleeves are non-sterile single patient use medical devices. An inflation source can be attached to the inflation valve on the sleeve. There is a hand pump provided as an inflation source to provide static compression. The systems are intended for hospital and outpatient use.. FDA UDI
Model / Reference
FL-FR-SR-L-SF-S FDA UDI
Description
The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the knee a Thigh sleeve from the knee to the crotch, a compression knee wrap, and a foot compression wrap. A hand pump is included to provide static compression for compression therapy. The AeroWrap™ Full Leg gradient compression system sleeves are non-sterile single patient use medical devices. An inflation source can be attached to the inflation valve on the sleeve. There is a hand pump provided as an inflation source to provide static compression. The systems are intended for hospital and outpatient use.. FDA UDI

Identifiers

Catalog Number
FL-FR-SR-L-SF-S FDA UDI
Primary DI / UDI-DI
00850051939688 FDA UDI
FDA Product Code
MHW FDA UDI
GMDN Term
Multi-chamber venous compression system garment, single-use 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multi-chamber venous compression system garment, single-use

AeroWrap™ Full Leg by Sun-Scientific Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-chamber venous compression system garment, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sun-Scientific Inc.

Sources (1)

  • FDA UDI 299baf2a-b831-4e95-a7c6-c8d3d1ed32b9 36 fields · synced May 30, 2026