AeroDVx ™ DV-USBS

GUDID 00856525007570

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 AeroDVx™ gradient compression sleeve is composed of a family of non-sterile single patient use medical devices. 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. The AeroDVx ™ Gradient Compression Sleeve is available in four sizes and two different lengths (standard and short). The wrap is composed of two polyurethane laminates that are sealed together creating an internal bladder system. The bladder system contains circular and bar welds that were engineered with their spacing and location to provide gradient compression profile when worn and inflated. An inflation source is attached to the inflation valve on the sleeve. The insertion of the inflation source onto the check valve of pressure opens the leur valve so that the bladder can be inflated or deflated based on the direction of airflow. There will be two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, the AeroDVx™ Pump, to provide intermittent pneumatic compression and a hand pump to provide static compression. The system is intended for hospital and outpatient use.

SUN SCIENTIFIC, INC.

Intermittent venous compression system pump

• Primary Device ID: 00856525007570
• NIH Device Record Key: b7b29a0e-3af7-450c-bfc1-4c7bf247e33d
• Commercial Distribution Discontinuation: 2030-10-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroDVx ™
• Version Model Number: Small, Short, Unilateral
• Catalog Number: DV-USBS
• Company DUNS: 609397224
• Company Name: SUN SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9144795108
• Email: aalward@sun-scientific.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856525007570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183349

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-13
• Device Publish Date: 2019-11-05

On-Brand Devices [AeroDVx ™]

• 00856525007617: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007600: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007594: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007723: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007709: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007693: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007686: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007679: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007662: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007648: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007624: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007587: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007570: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007716: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn
• 00856525007631: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pn