ArtAssist AA-1000

GUDID 00860446000305

Limb compression device with automatic pressure cycling.

ACI MEDICAL LLC

Single-chamber venous compression system garment, reusable Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system

• Primary Device ID: 00860446000305
• NIH Device Record Key: df1a6745-4b3d-4d94-96f4-fc87be227549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArtAssist
• Version Model Number: AA-1000
• Catalog Number: AA-1000
• Company DUNS: 153761499
• Company Name: ACI MEDICAL LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com
• Phone: 7607444400
• Email: info@acimedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860446000305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131146

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by ACI MEDICAL LLC

• 00860446000305 - ArtAssist: 2018-07-06Limb compression device with automatic pressure cycling.
• 00860446000305 - ArtAssist: 2018-07-06 Limb compression device with automatic pressure cycling.
• 00860446000312 - APG Air-Plethysmograph: 2018-07-06 Pneumatic plethysmograph.
• 00860446000329 - VenaPulse: 2018-07-06 Pneumatic tourniquet to evacuate blood from limb.