FDA.reportPublic FDA data

TopCare health

Primary DI
10036800402840
Brand
TopCare health
Company
TOPCO ASSOCIATES, LLC
Model
036800402843
Device description
Sterile Antibacterial Waterproof, Watershield Tan Bandages, all one size, 1 IN x 3 IN
Published
2019-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036800402840PackageGS172In Commercial Distribution
00036800402843PrimaryGS10
60036800402845Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003680040284010036800402840
00036800402843000368004028430368004028430036800402843
6003680040284560036800402845

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cover adhesive strip, antimicrobialA small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
072943876
Device count
30
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10036800024899TopCare health0368000248922026-02-05
10036800024905TopCare health0368000249082026-01-30
80368000226834TopCare HealthTOP4045V2TOP4045V22026-01-27
10036800018836TopCare HealthDigital Wide-Tip Pregnancy TestN/A2025-03-03
10036800092508TOPCARE87-621-00087-621-0002016-09-12
10036800118123TOPCARE87-207-00087-207-0002016-09-12
10036800216584TopCare health0368002165872019-07-31
10036800216591TopCare health0368002165942019-07-31
10036800216607TopCare health0368002166002019-07-31
10036800232690TOPCARE87-691-00187-691-0012016-09-12
10036800232706TOPCARE87-605-00187-605-0012016-09-12
10036800232713TOPCARE87-736-00187-736-0012016-09-13
10036800250762TopCare Insulin Syringe0329122016-09-24
10036800250779TopCare Insulin Syringe0529122016-09-24
10036800250786TopCare Insulin Syringe1029122016-10-04
10036800250793TopCare Insulin Syringe0330082016-09-24
10036800250809TopCare Insulin Syringe0530082016-09-24
10036800250816TopCare Insulin Syringe1030082016-09-24
10036800250823TopCare Insulin Syringe0331082016-09-24
10036800250830TopCare Insulin Syringe0531082016-09-24

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