DVT Sleeve

GUDID 10816317023130

Flowtron Standard Sequential Calf Garment- fits up to 17 inch calf circumference.

RENU MEDICAL, INC

Multi-chamber venous compression system garment, reprocessed

• Primary Device ID: 10816317023130
• NIH Device Record Key: 3d72e30a-3a4f-447b-bf0c-1060b7e32091
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DVT Sleeve
• Version Model Number: RM-TRP 10
• 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	00816317023133 [Primary]
GS1	10816317023130 [Package]; Contains: 00816317023133; 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: 2017-02-23

On-Brand Devices [DVT Sleeve]

• 00861317023171: Flowtron bariatric sequential calf garment - fits up to 32 inch calf circumference
• 00861317023164: Sequential thigh garment fits up to 35 in thigh circumference
• 00861317023157: Flowtron sequential thigh garment, fits up to 28" thigh circumference.
• 10861317023147: Flowtron large sequential calf garment- fits up to 23 in. calf circumference.
• 10861317023130: Flowtron Standard Sequential Calf Garment- fits up to 17 inch calf circumference.
• 00816317023171: Flowtron bariatric sequential calf garment - fits up to 32 inch calf circumference
• 00816317023164: Sequential thigh garment fits up to 35 in thigh circumference
• 00816317023157: Flowtron sequential thigh garment, fits up to 28" thigh circumference.
• 10816317023147: Flowtron large sequential calf garment- fits up to 23 in. calf circumference.
• 10816317023130: Flowtron Standard Sequential Calf Garment- fits up to 17 inch calf circumference.