Medline DVT Sleeve

GUDID 10816317020276

Medline, DVT, Int, Calf, Foam, Med

RENU MEDICAL, INC

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• Primary Device ID: 10816317020276
• NIH Device Record Key: e0ecdd43-d72b-4fce-9b1b-46be7cc9932e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medline DVT Sleeve
• Version Model Number: RM-MDS601MD
• 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	00816317020279 [Primary]
GS1	10816317020276 [Package]; Contains: 00816317020279; 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 [Medline DVT Sleeve]

• 10861317023208: Medline, DVT, Intermittent, Thigh, Med
• 10861317023192: Medline, DVT, Intermittent, Calf, Lg
• 10861317023185: Medline, DVT, Intermittent, Calf, Med
• 10861317020283: Medline Vaso Force Sequential Calf, Med
• 10861317020276: Medline, DVT, Int, Calf, Foam, Med
• 10816317023208: Medline, DVT, Intermittent, Thigh, Med
• 10816317023192: Medline, DVT, Intermittent, Calf, Lg
• 10816317023185: Medline, DVT, Intermittent, Calf, Med
• 10816317020283: Medline Vaso Force Sequential Calf, Med
• 10816317020276: Medline, DVT, Int, Calf, Foam, Med