FDA.reportPublic FDA data

T.E.D.

Primary DI
50192253015414
Brand
T.E.D.
Company
Cardinal Health 200, LLC
Model
3221
Catalog number
3221
Device description
T.E.D. Anti-Embolism Elastic Stockings, Full Leg, Large Regular White, Nonsterile, Product Code 3221.
Published
2021-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
20192253015413PackageGS16In Commercial Distribution
50192253015414PackageGS16In Commercial Distribution
10192253015416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225301541320192253015413
5019225301541450192253015414
1019225301541610192253015416

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

Regulatory Flags#

DUNS number
961027315
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
false
Expiration date on label
true
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
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

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