MedHealth

GUDID 16975298105120

DVT THIGH GARMENT LARGE

Medhealth Medical Limited

Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system

• Primary Device ID: 16975298105120
• NIH Device Record Key: 1868454d-abac-408c-b617-60486f27d0dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedHealth
• Version Model Number: 830L
• Company DUNS: 526120281
• Company Name: Medhealth Medical Limited
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	06975298105123 [Primary]
GS1	16975298105120 [Package]; Contains: 06975298105123; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	26975298105127 [Package]; Package: Outer Carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201532

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: 2023-09-25
• Device Publish Date: 2023-09-15

On-Brand Devices [MedHealth]

• 06975298105031: Portable DVT
• 06975298105024: DVT pump
• 06975298105055: DVT pump
• 06975298105048: DVT pump
• 16975298105151: DVT FOOT GARMENT LARGE
• 16975298105144: DVT FOOT GARMENT MEDIUM
• 16975298105120: DVT THIGH GARMENT LARGE
• 16975298105113: DVT THIGH GARMENT MEDIUM
• 16975298105106: DVT THIGH GARMENT SMALL
• 16975298105090: DVT CALF GARMENT XL
• 16975298105083: DVT CALF GARMENT LARGE
• 16975298105076: DVT CALF GARMENT MEDIUM
• 16975298105069: DVT CALF GARMENT SMALL