FDA.report

TopCare health

Primary DI
10036800359571
Brand
TopCare health
Company
TOPCO ASSOCIATES, LLC
Model
036800771437
Device description
Paper Tape, 1 IN x 10 YDS (2.5 cm x 9.1 m)
Published
2020-07-13
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
true

Related Records

Contact Domains

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10036800359571PackageGS172In Commercial Distribution
20036800771431PackageGS172In Commercial Distribution
00036800771437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1003680035957110036800359571
2003680077143120036800771431
00036800771437000368007714370368007714370036800771437

GMDN Terms

TermDefinition
Basic skin adhesive tapeA long and narrow flexible band of fabric, plastic, paper, or other material, coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter, lamp); it is not hypoallergenic or waterproof. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
18884230139topcare@topco.com

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
true
Sterilization required before use
false

Other Devices From This Company

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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