APG Air-Plethysmograph APG-1000

GUDID 00860446000312

Pneumatic plethysmograph.

ACI MEDICAL LLC

Limb plethysmograph

• Primary Device ID: 00860446000312
• NIH Device Record Key: 425f2d88-00a7-4632-9891-a19ff29ff9f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APG Air-Plethysmograph
• Version Model Number: APG-1000
• Catalog Number: APG-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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860446000312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881291

FDA Product Code

• JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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