AeroDVx™, Medium/Large Flex Bilateral DV-FMLB

GUDID 00856525007112

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, and attached and unattached sock. 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: 00856525007112
• NIH Device Record Key: 25a5e076-5a70-40a1-99a9-2723291d326f
• Commercial Distribution Discontinuation: 2030-10-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroDVx™, Medium/Large Flex Bilateral
• Version Model Number: Medium/Large Flex Bilateral
• Catalog Number: DV-FMLB
• 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	00856525007112 [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: 2021-07-29
• Device Publish Date: 2021-07-21

Devices Manufactured by SUN SCIENTIFIC, INC.

• 00850051939558 - Knee Compression Wrap Large: 2024-10-03 Aero-Wrap™ Knee Compression Wrap is designed to provide therapeutic compression therapy, in the inpatient and outpatient setti
• 00850051939527 - CopperUnder sock Small/Medium: 2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester small/medium
• 00850051939534 - CopperUnder sock Large: 2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester Large
• 00850051939541 - CopperUnder sock Extra Large: 2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester Extra Large
• 00850051939367 - ExuCare Scalp Large: 2024-08-26 ExuCare Scalp is a wrap dressing designed to provide drainage absorption for the Head
• 00850051939374 - ExuCare Scalp Pediatric: 2024-08-26 ExuCare Scalp is a wrap dressing designed to provide drainage absorption for the Head
• 00850051939381 - ExuCare Large with foot: 2024-08-08 A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury t
• 00850051939398 - Exorb Ankle Large: 2024-08-08 A wound cover that wraps around the ankle which is intended to be used as an initial, short-term treatment after injury that con