FDA.reportPublic FDA data

MEDI

Primary DI
04064985278799
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
JU35007666
Device description
!GERMAN JUXTAFIT PREM LOWR LEG 36CM XXXL
Published
2021-06-07
Public version status
Update
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
04064985278799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064985278799040649852787994064985278799

GMDN Terms#

Term, Definition table
TermDefinition
Compression bandaging kitA collection of various types of non-sterile 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 (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 or 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
00636257215913MEDIDW51L522026-08-21
00636257215920MEDIDW51L532026-08-21
00636257215937MEDIDW51L542026-08-21
00636257215944MEDIDW51R522026-08-21
00636257215951MEDIDW51R532026-08-21
00636257215968MEDIDW51R542026-08-21
04068903520939MEDIK2102512026-08-21
04068903520946MEDIK2102522026-08-21
04068903520953MEDIK2102532026-08-21
04068903520960MEDIK2102542026-08-21
04068903520977MEDIK2102552026-08-21
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

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