FLOWTRON ACS800

GUDID 05055982700221

DVT Prevention Compression Pump - FLOWTRON PUMP OPERATING ROOM U

Arjohuntleigh AB

Intermittent venous compression system

• Primary Device ID: 05055982700221
• NIH Device Record Key: f5bc65f1-df59-4602-81ef-f853490b44b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLOWTRON ACS800
• Version Model Number: 513003OR
• Company DUNS: 355804758
• Company Name: Arjohuntleigh AB
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055982700221 [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 ACS800]

• 05055982700245: DVT Prevention Compression Pump - FLOWTRON PUMP OPERATING ROOM U
• 05055982700238: DVT Prevention Compression Pump - FLOWTRON PUMP USA
• 05055982700221: DVT Prevention Compression Pump - FLOWTRON PUMP OPERATING ROOM U
• 05055982700214: DVT Prevention Compression Pump - FLOWTRON PUMP USA