Huntleigh

GUDID 30817357021401

Huntleigh DVT Flowtron Calf

HYGIA HEALTH SERVICES, INC.

Single-chamber venous compression system garment, reprocessed

• Primary Device ID: 30817357021401
• NIH Device Record Key: 60aae94e-a593-4551-91b8-fdf1332a2293
• Commercial Distribution Discontinuation: 2019-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Huntleigh
• Version Model Number: L501-M
• Company DUNS: 177939027
• Company Name: HYGIA HEALTH SERVICES, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817357021407 [Primary]
GS1	30817357021401 [Package]; Contains: 10817357021407; Package: Box [10 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012654

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: 2021-03-19
• Device Publish Date: 2016-09-24

On-Brand Devices [Huntleigh]

• 30817357021807: Huntleigh DVT Flowtron Thigh 28in.
• 30817357021777: Huntleigh DVT Flowtron Thigh 35in.
• 30817357021456: Huntleigh Lg Compression Foot
• 30817357021401: Huntleigh DVT Flowtron Calf
• 30817357021371: Huntleigh Regular Compression Foot
• 30817357021340: Huntleigh DVT Flowtron Calf 23in.
• 30817357020138: Huntleigh DVT Flowtron Calf 17in.