FDA.reportPublic FDA data

MEDI

Primary DI
00636257024478
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
55012
Device description
ESPRIT CCL2 ARMSLV W/TB STND CARM SZ II
Published
2016-08-31
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
00636257024478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257024478006362570244786362570244780636257024478

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 intended for use in the home or a clinical setting. 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
00674854000013SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000020SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000037SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000044SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000068SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000075SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000082SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000099SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000105SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000112SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000129SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000136SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000143SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000150SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000167SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000174SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000181SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000198SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000204SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000211SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000228SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000235SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000242SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000259SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000266SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000273SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000280SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000297SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000303SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000310SOFT SOCK ®Thuasne LLCDWL2018-12-31