FDA.reportPublic FDA data

MEDI

Primary DI
04026399566589
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
55013
Device description
ESPRIT CCL2 ARMSLV W/TB STND CARM SZ III
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
04026399566589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026399566589040263995665894026399566589

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636257213469MEDIDB1812026-05-07
00636257213551MEDISP171N12026-05-07
00636257213568MEDISP171N22026-05-07
00636257213575MEDISP171N32026-05-07
00636257213582MEDISP171N42026-05-07
00636257213599MEDISP171N52026-05-07
00636257213605MEDISP172N12026-05-07
00636257213612MEDISP172N22026-05-07
00636257213629MEDISP172N32026-05-07
00636257213636MEDISP172N42026-05-07
00636257213643MEDISP172N52026-05-07
00636257213650MEDISM171N12026-05-07
00636257213667MEDISM171N22026-05-07
00636257213674MEDISM171N32026-05-07
00636257213681MEDISM171N42026-05-07
00636257213698MEDISM171N52026-05-07
00636257213704MEDISM172N12026-05-07
00636257213711MEDISM172N22026-05-07
00636257213728MEDISM172N32026-05-07
00636257213735MEDISM172N42026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253015980T.E.D.Cardinal Health 200, LLCDWL2026-05-20
08300496042921SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042938SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042945SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042952SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042969SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042976SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496053767SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496053774SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496053781SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496062585SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496063667SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496067535SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
10192253015881T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015904T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015911T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015928T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015591T.E.D.Cardinal Health 200, LLCDWL2024-06-10
G420021Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420022Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420101Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420102Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420103Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420104Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420106Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420201Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420202Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420300Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420301Compression StockingGottfried Medical, Inc.DWL2023-08-15
G420302Compression StockingGottfried Medical, Inc.DWL2023-08-15