CTC DVT Sleeve

GUDID 10816317020351

VasoPress Calf 32in. Sleeve

RENU MEDICAL, INC

Multi-chamber venous compression system garment, reprocessed

• Primary Device ID: 10816317020351
• NIH Device Record Key: 74fae605-59db-45d3-8a48-4a3d4acb0c67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CTC DVT Sleeve
• Version Model Number: RM-VP-501B
• 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	00816317020354 [Primary]
GS1	10816317020351 [Package]; Contains: 00816317020354; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093658

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 [CTC DVT Sleeve]

• 00861317022952: VasoGrad Medium Thigh 29in. Sleeve
• 10861317022942: VasoGrad Lg Thigh 36in. Sleeve
• 10861317020436: VasoPress Medium Thigh 29in. Sleeve
• 10861317020429: VasoPress Lg Thigh 36in. Sleeve
• 10861317020412: VasoPress VP520L Foot
• 10861317020405: VasoPress Foot R or L
• 10861317020399: VasoPress Medium Calf 18in. Sleeve - Green
• 10861317020382: VasoPress Medium Calf 18in. Sleeve
• 10861317020375: VasoPress Lg Calf 24in. Sleeve - Green
• 10861317020368: VasoPress Lg Calf 24in. Sleeve
• 10861317020351: VasoPress Calf 32in. Sleeve
• 10861317020344: VasoGrad Medium Calf 18in. Sleeve
• 10861317020337: VasoGrad Lg Calf 24in. Sleeve
• 00816317022952: VasoGrad Medium Thigh 29in. Sleeve
• 10816317022942: VasoGrad Lg Thigh 36in. Sleeve
• 10816317020436: VasoPress Medium Thigh 29in. Sleeve
• 10816317020429: VasoPress Lg Thigh 36in. Sleeve
• 10816317020412: VasoPress VP520L Foot
• 10816317020405: VasoPress Foot R or L
• 10816317020399: VasoPress Medium Calf 18in. Sleeve - Green
• 10816317020382: VasoPress Medium Calf 18in. Sleeve
• 10816317020375: VasoPress Lg Calf 24in. Sleeve - Green
• 10816317020368: VasoPress Lg Calf 24in. Sleeve
• 10816317020351: VasoPress Calf 32in. Sleeve
• 10816317020344: VasoGrad Medium Calf 18in. Sleeve
• 10816317020337: VasoGrad Lg Calf 24in. Sleeve