FDA.report

MEDI

Primary DI
00636257097014
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
CJF525R0
Device description
JF ESSNTLS-45CM-UPC BLK LEGw/K-RIGHT-XXS
Published
2025-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MDRBINDER, MEDICAL, THERAPEUTIC

Product Code Classifications

CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00636257097014PrimaryGS10

GMDN Terms

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

Contacts

PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags

DUNS number
960754430
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00636257211281MEDIKCOR2CM12026-03-17
00636257211298MEDIKCOR2CM22026-03-17
00636257211304MEDIKCOR2CM32026-03-17
00636257211311MEDIKCOR2CM42026-03-17
00636257211328MEDIKCOR2LT12026-03-17
00636257211335MEDIKCOR2LT22026-03-17
00636257211342MEDIKCOR2LT32026-03-17
00636257211359MEDIKCOR2LT42026-03-17
00636257211366MEDIKCOR2MC12026-03-17
00636257211373MEDIKCOR2MC22026-03-17
00636257211380MEDIKCOR2MC32026-03-17
00636257211397MEDIKCOR2MC42026-03-17
00636257211403MEDIKBST2DR12026-03-17
00636257211410MEDIKBST2DR22026-03-17
00636257211427MEDIKBST2DR32026-03-17
00636257211434MEDIKBST2DR42026-03-17
00636257211441MEDIKBST2FG12026-03-17
00636257211458MEDIKBST2FG22026-03-17
00636257211465MEDIKBST2FG32026-03-17
00636257211472MEDIKBST2FG42026-03-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00636257043066MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043073MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043080MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043097MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043103MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043110MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043127MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043134MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043141MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043158MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043165MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043172MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043189MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043196MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043202MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043219MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047507MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047514MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047521MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047538MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047545MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047552MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047569MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047576MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047583MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047590MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00745129331610Cflex Reduce Full Leg SM SM SM Tall Left BeigeSIGVARIS INCMDR2025-08-15
00745129331627Cflex Reduce Full Leg LG LG LG Tall Left BlackSIGVARIS INCMDR2025-08-15
00745129331634Cflex Reduce Full Leg LG LG LG Tall Left BeigeSIGVARIS INCMDR2025-08-15
00745129331641Cflex Reduce Full Leg SM SM SM Reg Left BlackSIGVARIS INCMDR2025-08-15