FDA.reportPublic FDA data

Juzo Soft

Primary DI
00640095233909
Brand
Juzo Soft
Company
Julius Zorn, Inc.
Model
2002ADSH00 IV
Catalog number
23390
Device description
30-40 mmHg, Soft, Knee, OT, Short, Trend, IV
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQLSTOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00640095233909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00640095233909006400952339096400952339090640095233909

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)222-4999customercare@juzousa.com

Regulatory Flags#

DUNS number
123197535
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00640095132424Juzo Custom Compression Garments3021KT.MTM132422023-09-08
00640095132431Juzo Custom Compression Garments3021KTHL.MTM132432023-09-08
00640095132448Juzo Custom Compression Garments3022KT.MTM132442023-09-08
00640095132455Juzo Custom Compression Garments3022KTHL.MTM132452023-09-08
00640095132462Juzo Custom Compression Garments3023KT.MTM132462023-09-08
00640095132509Juzo Custom Compression Garments3021COKT.MTM132502023-09-08
00640095132516Juzo Custom Compression Garments3022COKT.MTM132512023-09-08
00640095136255Juzo Custom Compression Garments3021SVKT.MTM136252023-09-08
00640095136262Juzo Custom Compression Garments3022SVKT.MTM136262023-09-08
00640095208860Juzo Custom Compression Garments3021TH.MTM208862023-09-08
00640095208877Juzo Custom Compression Garments3022TH.MTM208872023-09-08
00640095208884Juzo Custom Compression Garments3021THSG.MTM208882023-09-08
00640095208891Juzo Custom Compression Garments3022THSG.MTM208892023-09-08
00640095208907Juzo Custom Compression Garments3021TO.MTM208902023-09-08
00640095208914Juzo Custom Compression Garments3022TO.MTM208912023-09-08
00640095208921Juzo Custom Compression Garments3021TOSG.MTM208922023-09-08
00640095208938Juzo Custom Compression Garments3022TOSG.MTM208932023-09-08
00640095208945Juzo Custom Compression Garments3021SVTH.MTM208942023-09-08
00640095208952Juzo Custom Compression Garments3022SVTH.MTM208952023-09-08
00640095208969Juzo Custom Compression Garments3021SVTHSG.MTM208962023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613378196157862W-CUSTOM ECF2 AGT WaistAttachment UNI °° BlackSIGVARIS INCFQL2026-05-18
07613378196164862T-CUSTOM ECF2 AG SoftTop UNI °° BlackSIGVARIS INCFQL2026-05-18
07613378196553862T-CUSTOM ECF2 AG SoftTop UNI BlackSIGVARIS INCFQL2026-05-18
07613378196560862N-CUSTOM ECF2 AG SensinovaUnisex UNI BlackSIGVARIS INCFQL2026-05-18
07613378196942862T-CUSTOM ECF2 AG SoftTop UNI °° CaramelSIGVARIS INCFQL2026-05-18
07613378197338862T-CUSTOM ECF2 AG SoftTop UNI CaramelSIGVARIS INCFQL2026-05-18
07613378197345862N-CUSTOM ECF2 AG SensinovaUnisex UNI CaramelSIGVARIS INCFQL2026-05-18
07613378197727862T-CUSTOM ECF2 AG SoftTop UNI °° GreySIGVARIS INCFQL2026-05-18
07613378198113862T-CUSTOM ECF2 AG SoftTop UNI GreySIGVARIS INCFQL2026-05-18
07613378198120862N-CUSTOM ECF2 AG SensinovaUnisex UNI GreySIGVARIS INCFQL2026-05-18
07613378198502862T-CUSTOM ECF2 AG SoftTop UNI °° SavannaSIGVARIS INCFQL2026-05-18
07613378198892862T-CUSTOM ECF2 AG SoftTop UNI SavannaSIGVARIS INCFQL2026-05-18
07613378198908862N-CUSTOM ECF2 AG SensinovaUnisex UNI SavannaSIGVARIS INCFQL2026-05-18
07613378199288862T-CUSTOM ECF2 AG SoftTop UNI °° SkinSIGVARIS INCFQL2026-05-18
07613378199677862T-CUSTOM ECF2 AG SoftTop UNI SkinSIGVARIS INCFQL2026-05-18
07613378199684862N-CUSTOM ECF2 AG SensinovaUnisex UNI SkinSIGVARIS INCFQL2026-05-18
07613378277504862N-CUSTOM ECF2 AG SensinovaUnisex UNI marineSIGVARIS INCFQL2026-05-18
07613378277511862T-CUSTOM ECF2 AG SoftTop UNI marineSIGVARIS INCFQL2026-05-18
07613378277900862T-CUSTOM ECF2 AG SoftTop UNI °° marineSIGVARIS INCFQL2026-05-18
08300496033981SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496071099SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073109SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073116SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073123SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073130SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073147SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
07613378199295862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° SkinSIGVARIS INCFQL2026-03-25
07613378196195862T-CUSTOM ECF2 AF SoftTop UNI °° BlackSIGVARIS INCFQL2026-03-18
07613378196584862T-CUSTOM ECF2 AF SoftTop UNI BlackSIGVARIS INCFQL2026-03-18
07613378196591862N-CUSTOM ECF2 AF SensinovaUnisex UNI BlackSIGVARIS INCFQL2026-03-18