FDA.reportPublic FDA data

MEDI

Primary DI
04051526820647
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
2Z90702
Device description
30-40 MV HARMONY SL GAUNTLET CARAMEL II
Published
2020-04-06
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
DWLStocking, medical support (to prevent pooling of blood in legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04051526820647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051526820647040515268206474051526820647

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 normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for a hospitalized patient. 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
00636257221358MEDISTS04352026-07-20
00636257221365MEDISTS04372026-07-20
00636257221372MEDISTS04392026-07-20
00636257221389MEDISTS04412026-07-20
00636257221396MEDISTS04432026-07-20
00636257221402MEDISTS04452026-07-20
00636257221419MEDISTS04472026-07-20
00636257221426MEDISTS05352026-07-20
00636257221433MEDISTS05372026-07-20
00636257221440MEDISTS05392026-07-20
00636257221457MEDISTS05412026-07-20
00636257221464MEDISTS05432026-07-20
00636257221471MEDISTS05452026-07-20
00636257221488MEDISTS05472026-07-20
00636257221495MEDISTS06352026-07-20
00636257221501MEDISTS06362026-07-20
00636257221563MEDISTS06372026-07-20
00636257221570MEDISTS06382026-07-20
00636257221587MEDISTS06392026-07-20
00636257221594MEDISTS06402026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08300496073888SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073895SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073901SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073918SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073925SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073932SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073949SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073956SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073963SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073970SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073987SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073994SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074007SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074014SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074021SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074038SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074045SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074052SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074069SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074076SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074083SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074090SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074106SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074113SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074120SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074137SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074144SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074151SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074168SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074175SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16