862C-CUSTOM ECF2 AD SoftTop UNI °° Black 320596

GUDID 07613378196225

A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb, however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.

SIGVARIS INC

Compression/pressure sock/stocking, single-use

• Primary Device ID: 07613378196225
• NIH Device Record Key: f61ef3fa-cd73-45e1-bea0-83eef9c904c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 862C-CUSTOM ECF2 AD SoftTop UNI °° Black
• Version Model Number: 320596
• Catalog Number: 320596
• Company DUNS: 189738719
• Company Name: SIGVARIS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613378196225 [Primary]

FDA Product Code

• FQL: Stocking, Medical Support (For General Medical Purposes)

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: 2025-07-21
• Device Publish Date: 2025-07-11

Devices Manufactured by SIGVARIS INC

• 00745129330835 - 442C Motion UP25 20-30 mmHg U LM White: 2025-08-25 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 00745129330842 - 442C Motion UP25 20-30 mmHg U LS White: 2025-08-25 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 00745129330859 - 442C Motion UP25 20-30 mmHg U ML White: 2025-08-25 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 00745129331610 - Cflex Reduce Full Leg SM SM SM Tall Left Beige: 2025-08-25 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129331627 - Cflex Reduce Full Leg LG LG LG Tall Left Black: 2025-08-25 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129331634 - Cflex Reduce Full Leg LG LG LG Tall Left Beige: 2025-08-25 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129331641 - Cflex Reduce Full Leg SM SM SM Reg Left Black: 2025-08-25 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129331658 - Cflex Reduce Full Leg SM SM SM Reg Left Beige: 2025-08-25 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff