AeroDVx ™ DV-BMBS

GUDID 00856525007662

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 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. 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.

SUN SCIENTIFIC, INC.

Intermittent venous compression system pump

• Primary Device ID: 00856525007662
• NIH Device Record Key: af484017-c948-40cd-9b3f-4df8ca4b9927
• Commercial Distribution Discontinuation: 2030-10-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroDVx ™
• Version Model Number: Medium,Short, Bilateral
• Catalog Number: DV-BMBS
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856525007662 [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