861W-CUSTOM ECF1 AGT WaistAttachment UNI Caramel 320468

GUDID 07613378197505

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: 07613378197505
• NIH Device Record Key: be988497-b0ba-467c-959a-b28581ef1e6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 861W-CUSTOM ECF1 AGT WaistAttachment UNI Caramel
• Version Model Number: 320468
• Catalog Number: 320468
• 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
• 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 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	07613378197505 [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: 2025-04-07
• Device Publish Date: 2025-03-28

Devices Manufactured by SIGVARIS INC

• 07613378196348 - 861P-CUSTOM ECF1 AT SoftTop MEN °° Black: 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 07613378196355 - 861P-CUSTOM ECF1 AT SoftTop FEM °° Black: 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 07613378196706 - 861P-CUSTOM ECF1 AT SoftTop MEN Black: 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 07613378196713 - 861P-CUSTOM ECF1 AT SoftTop FEM Black: 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 07613378196720 - 861W-CUSTOM ECF1 AGT WaistAttachment UNI Black: 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 07613378197123 - 861P-CUSTOM ECF1 AT SoftTop MEN °° Caramel: 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 07613378197130 - 861P-CUSTOM ECF1 AT SoftTop FEM °° Caramel: 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 07613378197482 - 861P-CUSTOM ECF1 AT SoftTop MEN Caramel: 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u