FDA.reportPublic FDA data

MEDI

Primary DI
00816635012802
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
KSPT1520L-BG
Device description
***USE KSPT1BG3 *SPOT COMPRESSION SOCKS
Published
2019-02-06
Public version status
Update
Distribution status
Not 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
00816635012802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816635012802008166350128028166350128020816635012802

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
00636257192283MEDI205572026-06-01
00636257214749MEDI107S512026-06-01
00636257214756MEDI107S522026-06-01
00636257214763MEDI107S532026-06-01
00636257214770MEDI107S542026-06-01
00636257214787MEDI107S552026-06-01
00636257214794MEDI107S562026-06-01
00636257214800MEDI107S572026-06-01
00636257214817MEDI108S512026-06-01
00636257214824MEDI108S522026-06-01
00636257214831MEDI108S532026-06-01
00636257214848MEDI108S542026-06-01
00636257214855MEDI108S552026-06-01
00636257214862MEDI108S562026-06-01
00636257214879MEDI108S572026-06-01
00636257214886MEDI195S512026-06-01
00636257214893MEDI195S522026-06-01
00636257214909MEDI195S532026-06-01
00636257214916MEDI195S542026-06-01
00636257214923MEDI195S552026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4200211Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4200221Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203081Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203091Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203311Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203321Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203331Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203341Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203351Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203361Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203371Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203381Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203391Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203411Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203421Compression StockingGottfried Medical, Inc.DWL2026-06-04