TopCare health

Basic Information

• Brand Name: TopCare health
• Primary DI: 00036800186002
• Version / Model: 036800186002
• Company Name: TOPCO ASSOCIATES, LLC
• Labeler DUNS: 072943876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-13
• Public Version: 2
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 0d150566-60a3-469c-b30f-395ef18e6900

Device Description

Waterproof Adhesive Tape, 1/2 IN x 10 YDS (1.27 cm x 9.1 m)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16866	Dressing-fixation skin adhesive tape, non-silicone	A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) 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 might have hypoallergenic and/or waterproof properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10036800107110	GS1	case	48	Not in Commercial Distribution	2023-11-02
Primary	00036800186002	GS1
Package	20036800186006	GS1	case	48	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]