Bigfoot Alcohol Prep Pads, 70% v/v Isopropyl Alcohol

Basic Information

• Brand Name: Bigfoot Alcohol Prep Pads, 70% v/v Isopropyl Alcohol
• Primary DI: 00850003506081
• Version / Model: FG-300145
• Catalog Number: FG-300145
• Company Name: Bigfoot Biomedical, Inc.
• Labeler DUNS: 079721177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-29
• Public Version: 1
• Public Version Date: 2021-07-07
• Public Version Status: New
• Public Device Record Key: f63155bb-f32f-4125-be77-b4b5b82d76a6

Device Description

Bigfoot Alcohol Prep Pads, 70% v/v Isopropyl Alcohol, 100CT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRJ	Disinfectant, Medical Devices	General Hospital	880.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61695	Skin-cleaning wipe, sterile	A sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850003506081	GS1