FDA.reportPublic FDA data

TopCare health

Primary DI
20036800649808
Brand
TopCare health
Company
TOPCO ASSOCIATES, LLC
Model
60002534
Published
2020-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
10036800649801PackageGS16In Commercial Distribution
20036800649808PackageGS16In Commercial Distribution
00036800649804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003680064980110036800649801
2003680064980820036800649808
00036800649804000368006498040368006498040036800649804

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
072943876
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
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
00036800216587TopCare health0368002165872019-07-31
00036800216600TopCare health0368002166002019-07-31
00036800413634TopCare health0368004136342019-10-31
00036800024892TopCare health0368000248922026-02-05
10036800024899TopCare health0368000248922026-02-05
00036800024908TopCare health0368000249082026-01-30
10036800024905TopCare health0368000249082026-01-30
00036800022683TopCare HealthTOP4045V2TOP4045V22026-01-27
80368000226834TopCare HealthTOP4045V2TOP4045V22026-01-27
20036800367436TopCare Premium Blood Glucose Meter8000-071642016-09-24
00036800250789TopCare Insulin Syringe1029122016-10-04
00036800250826TopCare Insulin Syringe0331082016-09-24
20036800367443TopCare Premium Blood Glucose Test Strips8000-071582016-09-24
20036800422159TopCare Premium Blood Glucose Test Strips8000-104432016-09-24
00036800250796TopCare Insulin Syringe0330082016-09-24
00036800250802TopCare Insulin Syringe0530082016-09-24
00036800250833TopCare Insulin Syringe0531082016-09-24
00036800250840TopCare Insulin Syringe1031082016-09-24
00036800250765TopCare Insulin Syringe0329122016-09-24
00036800250772TopCare Insulin Syringe0529122016-09-24

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