Flowtron

GUDID 15055982700785

DVT Prevention Compression Garment - FG200 FOOT GARMENT LARGE

Arjohuntleigh AB

Intermittent venous compression system

• Primary Device ID: 15055982700785
• NIH Device Record Key: 557cc38c-670e-4842-9577-349b15a041fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flowtron
• Version Model Number: FG200
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055982700788 [Unit of Use]
GS1	15055982700785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K965153

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]

• 15055982700884: DVT Prevention Compression Garment - L503-M CALF/THIGH
• 15055982700860: DVT Prevention Compression Garment - L501-M CALF
• 15055982700808: DVT Prevention Compression Garment - FG200 STERILE - FOOT GARMENT LARGE
• 15055982700785: DVT Prevention Compression Garment - FG200 FOOT GARMENT LARGE
• 15055982700778: DVT Prevention Compression Garment - FG100 STERILE - FOOT GARMENT REGULAR
• 15055982700754: DVT Prevention Compression Garment - FG100 - FOOT GARMENT REGULAR
• 15055982700747: DVT Prevention Compression Garment - DVT60L BARIATRIC CALF/THIGH
• 15055982700723: DVT Prevention Compression Garment - DVT40 LARGE CALF/THIGH
• 15055982700716: DVT Prevention Compression Garment - DVT 30 STERILE - CALF/THIGH
• 15055982700709: DVT Prevention Compression Garment - DVT30 CALF/THIGH
• 15055982700693: DVT Prevention Compression Garment - DVT20 LARGE CALF
• 15055982700686: DVT Prevention Compression Garment - DVT 10 STERILE CALF
• 15055982700679: DVT Prevention Compression Garment -DVT10 CALF
• 05055982786348: DVT Prevention Compression Garment -DVT5 CALF - Small