DJO Global DVT Sleeve

GUDID 10816317020023

Aircast VenaFlow Elite Foam Calf Cuff

RENU MEDICAL, INC

Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed Multi-chamber venous compression system garment, reprocessed

• Primary Device ID: 10816317020023
• NIH Device Record Key: 40dcfdee-5708-4b2e-afc1-703f4ff56fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DJO Global DVT Sleeve
• Version Model Number: RM-3050
• Company DUNS: 100439103
• Company Name: RENU MEDICAL, INC
• Device Count: 1
• 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: false
• 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	00816317020026 [Primary]
GS1	10816317020023 [Package]; Contains: 00816317020026; Package: CASE [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121145

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: 2019-08-02
• Device Publish Date: 2016-08-23

On-Brand Devices [DJO Global DVT Sleeve]

• 10861317022980: Aircast VenaFlow Elite Calf Cuff XL
• 10861317020030: Aircast VenaFlow Elite Foot Cuff
• 10861317020023: Aircast VenaFlow Elite Foam Calf Cuff
• 10861317020016: Aircast VenaFlow Elite Calf Cuff
• 10861317020009: Aircast VenaFlow Calf Cuff
• 10816317022980: Aircast VenaFlow Elite Calf Cuff XL
• 10816317020030: Aircast VenaFlow Elite Foot Cuff
• 10816317020023: Aircast VenaFlow Elite Foam Calf Cuff
• 10816317020016: Aircast VenaFlow Elite Calf Cuff
• 10816317020009: Aircast VenaFlow Calf Cuff