FDA.reportPublic FDA data

MEDI

Primary DI
00636257097779
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
CJFSS501
Device description
JUXTAFIT SHELF STRAP BLACK SMALL
Published
2025-03-28
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
MDRBINDER, MEDICAL, THERAPEUTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636257097779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257097779006362570977796362570977790636257097779

GMDN Terms#

Term, Definition table
TermDefinition
Compression bandaging kitA collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression layer (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home and healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags#

DUNS number
960754430
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00400000326986MEDISTS04352026-07-20
00400000326993MEDISTS04372026-07-20
00400000327006MEDISTS04392026-07-20
00400000327013MEDISTS04412026-07-20
00400000327020MEDISTS04432026-07-20
00400000327037MEDISTS04452026-07-20
00400000327044MEDISTS04472026-07-20
00400000327051MEDISTS05352026-07-20
00400000327068MEDISTS05372026-07-20
00400000327075MEDISTS05392026-07-20
00400000327082MEDISTS05412026-07-20
00400000327099MEDISTS05432026-07-20
00400000327105MEDISTS05452026-07-20
00400000327112MEDISTS05472026-07-20
00400000327129MEDISTS06352026-07-20
00400000327136MEDISTS06362026-07-20
00400000327143MEDISTS06372026-07-20
00400000327150MEDISTS06382026-07-20
00400000327167MEDISTS06392026-07-20
00400000327174MEDISTS06402026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00745129335069Envelo Arm Wrap Small Short BeigeSIGVARIS INCMDR2026-07-22
00745129335076Envelo Arm Wrap Small Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335083Envelo Arm Wrap Small Long BeigeSIGVARIS INCMDR2026-07-22
00745129335090Envelo Arm Wrap Max Small Short BeigeSIGVARIS INCMDR2026-07-22
00745129335106Envelo Arm Wrap Max Small Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335113Envelo Arm Wrap Max Small Long BeigeSIGVARIS INCMDR2026-07-22
00745129335120Envelo Arm Wrap Medium Short BeigeSIGVARIS INCMDR2026-07-22
00745129335137Envelo Arm Wrap Medium Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335144Envelo Arm Wrap Medium Long BeigeSIGVARIS INCMDR2026-07-22
00745129335151Envelo Arm Wrap Max Medium Short BeigeSIGVARIS INCMDR2026-07-22
00745129335168Envelo Arm Wrap Max Medium Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335175Envelo Arm Wrap Max Medium Long BeigeSIGVARIS INCMDR2026-07-22
00745129335182Envelo Arm Wrap Large Short BeigeSIGVARIS INCMDR2026-07-22
00745129334918Envelo Arm Wrap Max Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334925Envelo Arm Wrap Max Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334932Envelo Arm Wrap Max Large Long BlackSIGVARIS INCMDR2026-07-20
00745129334949Envelo Arm Wrap X-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334956Envelo Arm Wrap X-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334963Envelo Arm Wrap X-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129334970Envelo Arm Wrap Max X-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334987Envelo Arm Wrap Max X-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334994Envelo Arm Wrap Max X-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129335007Envelo Arm Wrap XX-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129335014Envelo Arm Wrap XX-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129335021Envelo Arm Wrap XX-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129335038Envelo Arm Wrap Max XX-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129335045Envelo Arm Wrap Max XX-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129335052Envelo Arm Wrap Max XX-Large Long BlackSIGVARIS INCMDR2026-07-20
08300496073246SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
08300496073253SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15