ABC

Basic Information

• Brand Name: ABC
• Primary DI: 00195515047104
• Version / Model: 195515047104
• Company Name: AMAZON.COM SERVICES LLC
• Labeler DUNS: 128990418
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2024-06-25
• Public Version: 1
• Public Version Date: 2024-07-03
• Public Version Status: New
• Public Device Record Key: c6a4bcda-1e5d-4caf-88ba-5ee98888c1ec

Device Description

Antibacterial Heavy-Duty Adhesive Bandages, 1 3/4 IN x 4 IN (44 MM x 101 MM)

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
47378	Skin-cover adhesive strip, antimicrobial	A 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 intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10195515047101	GS1	case	36	In Commercial Distribution
Primary	00195515047104	GS1
Unit of Use	60195515047106	GS1

Customer Contacts

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