183C MicroFiber Shades 15-20mmHg M B BlueButterfly 183CB24

GUDID 00745129317560

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 ID00745129317560
NIH Device Record Key69655a9b-6787-4530-8853-f96453357532
Commercial Distribution StatusIn Commercial Distribution
Brand Name183C MicroFiber Shades 15-20mmHg M B BlueButterfly
Version Model Number183C
Catalog Number183CB24
Company DUNS189738719
Company NameSIGVARIS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100745129317560 [Primary]

FDA Product Code

FQLStocking, Medical Support (For General Medical Purposes)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-20
Device Publish Date2025-02-12

Devices Manufactured by SIGVARIS INC

00745129315962 - Cflex Contain Full Leg MD MD MD Reg Right Black2025-02-20 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
00745129317522 - 143C MicroFiber Shades 15-20mmHg W A BlueButterfly2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129317539 - 143C MicroFiber Shades 15-20mmHg W B BlueButterfly2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129317546 - 143C MicroFiber Shades 15-20mmHg W C BlueButterfly2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129317553 - 183C MicroFiber Shades 15-20mmHg M A BlueButterfly2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129317560 - 183C MicroFiber Shades 15-20mmHg M B BlueButterfly2025-02-20A 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.
00745129317560 - 183C MicroFiber Shades 15-20mmHg M B BlueButterfly2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129317577 - 183C MicroFiber Shades 15-20mmHg M C Blue Butterflies2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
07613378105326 - 579 Melany Donning & Doffing Large2025-02-04 A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).

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