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Aero-Wrap® Arm

FDA UDI

Class I (US FDA UDI)

by Sun-Scientific Inc.

Identity

Trade Name
Aero-Wrap® Arm FDA UDI
Generic Name
Single-chamber venous compression system garment, reusable FDA UDI
Device Name
The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy. The Aero-Wrap® Arm gradient compression sleeve is a non-sterile single patient use medical device. The Aero-Wrap® Arm, Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s full arm covering the bicep and forearm. An inflation source can be 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 clinical and outpatient use. FDA UDI
Model / Reference
AWUE-LL, Large Right FDA UDI
Description
The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy. The Aero-Wrap® Arm gradient compression sleeve is a non-sterile single patient use medical device. The Aero-Wrap® Arm, Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s full arm covering the bicep and forearm. An inflation source can be 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 clinical and outpatient use. FDA UDI

Identifiers

Catalog Number
AWUE-LR FDA UDI
Primary DI / UDI-DI
00850051939350 FDA UDI
FDA Product Code
MHW FDA UDI
GMDN Term
Single-chamber venous compression system garment, reusable 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

Yes

FDA UDI

Category: Sequential venous compression systemSingle-chamber venous compression system garment, reusable

Aero-Wrap® Arm by Sun-Scientific Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-chamber venous compression system garment, reusable.

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 360488f2-d65e-4e06-b145-4f46ac478d37 36 fields · synced Jun 8, 2026