FLOWTRON ACS800

GUDID 05055982700221

DVT Prevention Compression Pump - FLOWTRON PUMP OPERATING ROOM U

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: 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