Kendall DVT Sleeve

GUDID 10816317024427

Kendall SCD Smartflow Express Sleeves, Knee Length Medium

RENU MEDICAL, INC

Multi-chamber venous compression system garment, reprocessed

• Primary Device ID: 10816317024427
• NIH Device Record Key: 7451bca6-7658-4f43-a07b-02568e3218fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kendall DVT Sleeve
• Version Model Number: RM-83022
• Company DUNS: 100439103
• Company Name: RENU MEDICAL, INC
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816317024420 [Primary]
GS1	10816317024427 [Package]; Contains: 00816317024420; Package: Case [5 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-04
• Device Publish Date: 2026-01-27

On-Brand Devices [Kendall DVT Sleeve]

• 10816317024441: Kendall SCD Smartflow Express Sleeves, Knee Length X-Large
• 10816317024434: Kendall SCD Smartflow Express Sleeves, Knee Length Large
• 10816317024427: Kendall SCD Smartflow Express Sleeves, Knee Length Medium