FDA.reportPublic FDA data

THERAFIRM SINGLES®

Primary DI
00721734050481
Brand
THERAFIRM SINGLES®
Company
Thuasne LLC
Model
T504E0330
Catalog number
DOPHC2030SL
Device description
Opaque Pantyhose Singles 6 pk. Dispenser 20-30 Sand Large
Published
2018-12-31
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

Product Codes#

Code, Name table
CodeName
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00721734150488PackageGS16In Commercial Distribution
00721734050481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721734150488007217341504887217341504880721734150488
00721734050481007217340504817217340504810721734050481

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
094737173
Device count
1
DM exempt
true
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
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
00721734050016THERAFIRM SINGLES®T500E0105DOKHC2030BS2018-12-31
00721734050061THERAFIRM SINGLES®T500E0130DOKHC2030SS2018-12-31
00721734050078THERAFIRM SINGLES®T500E0230DOKHC2030SM2018-12-31
00721734050085THERAFIRM SINGLES®T500E0330DOKHC2030SL2018-12-31
00721734050092THERAFIRM SINGLES®T500E0430DOKHC2030SXL2018-12-31
00721734050115THERAFIRM SINGLES®T501E0105DOKHO2030BS2018-12-31
00721734050122THERAFIRM SINGLES®T501E0205DOKHO2030BM2018-12-31
00721734050139THERAFIRM SINGLES®T501E0305DOKHO2030BL2018-12-31
00721734050146THERAFIRM SINGLES®T501E0405DOKHO2030BXL2018-12-31
00721734050160THERAFIRM SINGLES®T501E0130DOKHO2030SS2018-12-31
00721734050177THERAFIRM SINGLES®T501E0230DOKHO2030SM2018-12-31
00721734050184THERAFIRM SINGLES®T501E0330DOKHO2030SL2018-12-31
00721734050191THERAFIRM SINGLES®T501E0430DOKHO2030SXL2018-12-31
00721734050214THERAFIRM SINGLES®T502E0105DOTHC2030BS2018-12-31
00721734050221THERAFIRM SINGLES®T502E0205DOTHC2030BM2018-12-31
00721734050238THERAFIRM SINGLES®T502E0305DOTHC2030BL2018-12-31
00721734050245THERAFIRM SINGLES®T502E0405DOTHC2030BXL2018-12-31
00721734050269THERAFIRM SINGLES®T502E0130DOTHC2030SS2018-12-31
00721734050276THERAFIRM SINGLES®T502E0230DOTHC2030SM2018-12-31
00721734050283THERAFIRM SINGLES®T502E0330DOTHC2030SL2018-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542156HalyardMEDICAL ACTION INDUSTRIES INC.FQL2026-10-28
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04026358026703VenoTrain softBauerfeind AGDWL2016-10-07
04026358026710VenoTrain softBauerfeind AGDWL2016-10-07
04026358026727VenoTrain softBauerfeind AGDWL2016-10-07
04026358026741VenoTrain softBauerfeind AGDWL2016-10-07
04026358026857VenoTrain softBauerfeind AGDWL2016-10-07
04026358026871VenoTrain softBauerfeind AGDWL2016-10-07
04026358026888VenoTrain softBauerfeind AGDWL2016-10-07
04026358027298VenoTrain softBauerfeind AGDWL2016-10-07
04026358027304VenoTrain softBauerfeind AGDWL2016-10-07
04026358027359VenoTrain softBauerfeind AGDWL2016-10-07
04026358027366VenoTrain softBauerfeind AGDWL2016-10-07
04026358027434VenoTrain softBauerfeind AGDWL2016-10-07
04026358027441VenoTrain softBauerfeind AGDWL2016-10-07
04026358027458VenoTrain softBauerfeind AGDWL2016-10-07
04026358027465VenoTrain softBauerfeind AGDWL2016-10-07
04026358027595VenoTrain softBauerfeind AGDWL2016-10-07
04026358027762VenoTrain softBauerfeind AGDWL2016-10-07
04026358027830VenoTrain softBauerfeind AGDWL2016-10-07
04026358027854VenoTrain softBauerfeind AGDWL2016-10-07
04026358026598VenoTrain softBauerfeind AGDWL2016-10-07
04026358026666VenoTrain softBauerfeind AGDWL2016-10-07
04026358026680VenoTrain softBauerfeind AGDWL2016-10-07
04026358026734VenoTrain softBauerfeind AGDWL2016-10-07
04026358026840VenoTrain softBauerfeind AGDWL2016-10-07
04026358027274VenoTrain softBauerfeind AGDWL2016-10-07
04026358027281VenoTrain softBauerfeind AGDWL2016-10-07
04026358027373VenoTrain softBauerfeind AGDWL2016-10-07
04026358027380VenoTrain softBauerfeind AGDWL2016-10-07