FDA.reportPublic FDA data

T.E.D.

Primary DI
00884521167233
Brand
T.E.D.
Company
Cardinal Health, Inc.
Model
MKN35096
Catalog number
MKN35096
Device description
True content to be populated as part of rebranding
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
20884521167237PackageGS112Not in Commercial Distribution
00884521167233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088452116723720884521167237
00884521167233008845211672338845211672330884521167233

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.

Regulatory Flags#

DUNS number
080935429
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30884527016048Devon31145942311459422018-06-29
10884521170728Kendall507250722016-09-24
10884527023240Kerlix258525852018-06-23
10884527023295Kerlix507250722018-06-30
10884521744585Kendall8608U8608U2017-09-07
10884521744608Kendall8617U8617U2017-09-07
10884521744622Kendall8618U8618U2017-09-07
20884521100432SharpSafety8608U8608U2016-09-24
20884521100463Monoject8617U8617U2016-09-24
20884521100470Monoject8618U8618U2016-09-24
40884521023100Monoject31142222311422222016-09-24
10884521020511Monoject888124713788812471372018-06-30
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24
20884527000088Argyle888472450488847245042018-06-30
00884521144227Webcol16818168182018-06-22
10884521189652Monoject1186000444T1186000444T2016-09-24
10884527007110Argyle888816305588881630552016-09-24
20885380173537Curity7267G7267G2019-11-14
20885380173568Curity9024G9024G2019-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226440623ViveVIVE HEALTH LLCDWL2026-07-14
00810226440630ViveVIVE HEALTH LLCDWL2026-07-14
00810226440647ViveVIVE HEALTH LLCDWL2026-07-14
00810226440654ViveVIVE HEALTH LLCDWL2026-07-14
00810226440661ViveVIVE HEALTH LLCDWL2026-07-14
00810226440678ViveVIVE HEALTH LLCDWL2026-07-14
00810226440685ViveVIVE HEALTH LLCDWL2026-07-14
00810226440692ViveVIVE HEALTH LLCDWL2026-07-14
00810226440708ViveVIVE HEALTH LLCDWL2026-07-14
00810226440715ViveVIVE HEALTH LLCDWL2026-07-14
00810226440739ViveVIVE HEALTH LLCDWL2026-07-14
00810226440746ViveVIVE HEALTH LLCDWL2026-07-14
00810226440753ViveVIVE HEALTH LLCDWL2026-07-14
00810226440760ViveVIVE HEALTH LLCDWL2026-07-14
00810226440777ViveVIVE HEALTH LLCDWL2026-07-14
00810226440784ViveVIVE HEALTH LLCDWL2026-07-14
00810226440791ViveVIVE HEALTH LLCDWL2026-07-14
00810226440807ViveVIVE HEALTH LLCDWL2026-07-14
00810226440814ViveVIVE HEALTH LLCDWL2026-07-14
00810226440821ViveVIVE HEALTH LLCDWL2026-07-14
00048503515379Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515386Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515393Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515416Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515423Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515430Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515447Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515454Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515461Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515478Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22