ArjoHuntleigh DVT Sleeve

GUDID 10816317020238

Huntleigh Regular Compression Foot

RENU MEDICAL, INC

Multi-chamber venous compression system garment, reprocessed

• Primary Device ID: 10816317020238
• NIH Device Record Key: aeee4316-a8e7-48d8-ade0-0148ecf6edd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArjoHuntleigh DVT Sleeve
• Version Model Number: RM-FG100
• 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	00816317020231 [Primary]
GS1	10816317020238 [Package]; Contains: 00816317020231; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031559

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 [ArjoHuntleigh DVT Sleeve]

• 10861317020269: Huntleigh DVT Flowtron Thigh L503M
• 10861317020252: Huntleigh DVT Flowtron Calf L501M
• 10861317020245: Huntleigh Lg Compression Foot
• 10861317020238: Huntleigh Regular Compression Foot
• 10861317020221: Huntleigh DVT Flowtron Bariatric 32in. Garment
• 10861317020214: Huntleigh DVT Bariatric Flowtron Calf
• 10861317020207: Huntleigh DVT Flowtron Thigh 35in. Garment
• 10861317020191: Huntleigh DVT Flowtron Thigh 28in. Garment
• 10861317020184: Huntleigh DVT Flowtron Calf 23in. Garment
• 10861317020177: Huntleigh DVT Flowtron Calf 17in. Garment
• 10816317020269: Huntleigh DVT Flowtron Thigh L503M
• 10816317020252: Huntleigh DVT Flowtron Calf L501M
• 10816317020245: Huntleigh Lg Compression Foot
• 10816317020238: Huntleigh Regular Compression Foot
• 10816317020221: Huntleigh DVT Flowtron Bariatric 32in. Garment
• 10816317020214: Huntleigh DVT Bariatric Flowtron Calf
• 10816317020207: Huntleigh DVT Flowtron Thigh 35in. Garment
• 10816317020191: Huntleigh DVT Flowtron Thigh 28in. Garment
• 10816317020184: Huntleigh DVT Flowtron Calf 23in. Garment
• 10816317020177: Huntleigh DVT Flowtron Calf 17in. Garment