FDA.reportPublic FDA data

MEDI

Primary DI
00636257046531
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
KBK1L5N0
Device description
"20-30 TRANS SHRINK BK 18"" LONG BK SZ 0"
Published
2025-10-03
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
IPMCOVER, LIMB

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636257046531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257046531006362570465316362570465310636257046531

GMDN Terms#

Term, Definition table
TermDefinition
Limb-worn device hygienic coverA device made of fabric or harder materials designed to cover an external prosthetic or orthotic device worn on a limb (e.g., cast, foot orthosis), or an external fixation system for a limb, primarily to function as a hygienic barrier to protect the device and patient from contamination; it is not intended to be applied directly to the limb for a therapeutic purpose. This is a reusable device.

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
00636257044988MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046197MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046203MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046210MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046463MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046470MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046487MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046494MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046500MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046517MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046524MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046548MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046555MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046562MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046579MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046586MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046593MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046609MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046616MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046623MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046630MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046647MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046654MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046661MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046678MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046685MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046692MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046708MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046715MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046722MEDIMEDI MANUFACTURING, INC.IPM2025-10-03