FLOWTRON EXCEL

GUDID 05055982700016

DVT Prevention Compression Pump - FLOWTRON EXCEL AC550 PUMP

Arjohuntleigh AB

Intermittent venous compression system

• Primary Device ID: 05055982700016
• NIH Device Record Key: 0ad709e8-9be1-4d4f-9a42-bde9bb796178
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLOWTRON EXCEL
• Version Model Number: 247001
• 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	05055982700016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961166

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: 4
• Public Version Date: 2019-04-29
• Device Publish Date: 2016-09-23

Devices Manufactured by Arjohuntleigh AB

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• 05059441401124 - Maxi Move 5: 2025-03-03 Maxi Move 5 Mobile Floor Lifter - (H) SWL 600 lb / 272 kg, (E) Extra Low Height. w/Scale
• 05059441401148 - Maxi Move 5: 2025-03-03 Maxi Move 5 Mobile Floor Lifter - (H) SWL 600 lb / 272 kg, (E) Extra Low Height
• 05059441401179 - Maxi Move 5: 2025-03-03 Maxi Move 5 Mobile Floor Lifter - (H) SWL 600 lb / 272 kg, (L) Low Height. w/Motion Assist
• 05059441401186 - Maxi Move 5: 2025-03-03 Maxi Move 5 Mobile Floor Lifter - (H) SWL 600 lb / 272 kg, (L) Low Height. w/Scale
• 05059441401209 - Maxi Move 5: 2025-03-03 Maxi Move 5 Mobile Floor Lifter - (H) SWL 600 lb / 272 kg, (L) Low Height