Covidien DVT Sleeve

GUDID 10816317020085

Kendall SCD Express Thigh Lg

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: 10816317020085
• NIH Device Record Key: 278e12b8-cb3e-42bc-b3d4-14f7a49ed081
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Covidien DVT Sleeve
• Version Model Number: RM-9780
• 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	00816317020088 [Primary]
GS1	10816317020085 [Package]; Contains: 00816317020088; Package: CASE [3 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 [Covidien DVT Sleeve]

• 00861317023232: Kendall SCD - Lg Knee pr
• 10861317023086: Kendall SCD - Small Thigh pr
• 00861317023072: Kendall SCD - Medium Thigh pr
• 10861317022911: Kendall SCD Express Thigh Small
• 10861317022904: Kendall SCD Express Foot/Lg
• 00861317022891: Kendall SCD Express Foot/Reg
• 10861317022881: Kendall SCD - Knee Length pr
• 10861317020092: Kendall SCD Express Knee/Lg
• 10861317020085: Kendall SCD Express Thigh Lg
• 10861317020078: Kendall SCD Express Thigh Medium
• 10861317020061: Kendall SCD Express Knee/Med
• 10861317020054: Kendall ImPad Rigid Sole Foot Covers Lg. Pair
• 10861317020047: Kendall Impad Rigid Sole Foot Covers Reg. Pair
• 00816317023232: Kendall SCD - Lg Knee pr
• 10816317023086: Kendall SCD - Small Thigh pr
• 00816317023072: Kendall SCD - Medium Thigh pr
• 10816317022911: Kendall SCD Express Thigh Small
• 10816317022904: Kendall SCD Express Foot/Lg
• 00816317022891: Kendall SCD Express Foot/Reg
• 10816317022881: Kendall SCD - Knee Length pr
• 10816317020092: Kendall SCD Express Knee/Lg
• 10816317020085: Kendall SCD Express Thigh Lg
• 10816317020078: Kendall SCD Express Thigh Medium
• 10816317020061: Kendall SCD Express Knee/Med
• 10816317020054: Kendall ImPad Rigid Sole Foot Covers Lg. Pair