Flowtron Tri Pulse

GUDID 15055982700839

DVT Prevention Compression Garment - TRP30 CALF/THIGH

Arjohuntleigh AB

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: 15055982700839
• NIH Device Record Key: 0f8bd8db-a55e-4a4b-ac57-8d5a4dd80051
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flowtron Tri Pulse
• Version Model Number: TRP30
• Company DUNS: 355804758
• Company Name: Arjohuntleigh AB
• Device Count: 10
• DM Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com
• Phone: 1(800) 323-1245
• Email: us.info@arjo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055982700832 [Unit of Use]
GS1	15055982700839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133119

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: 2016-09-23

On-Brand Devices [Flowtron Tri Pulse]

• 15055982700853: DVT Prevention Compression Garment - TRP60L BARIATRIC CALF/THIGH
• 15055982700846: DVT Prevention Compression Garment - TRP40 LARGE CALF/THIGH
• 15055982700839: DVT Prevention Compression Garment - TRP30 CALF/THIGH
• 15055982700822: DVT Prevention Compression Garment - TRP20 GARMENT LARGE CALF
• 15055982700815: DVT Prevention Compression Garment - TRP10 GARMENT CALF