SAPS health + Alcohol Pads

Basic Information

• Brand Name: SAPS health + Alcohol Pads
• Primary DI: 00860000526586
• Version / Model: 6586
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Labeler DUNS: 783518983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-06
• Public Version: 2
• Public Version Date: 2020-08-07
• Public Version Status: Update
• Public Device Record Key: ea95f9b2-8c47-40de-a83a-2dd4569ae468

Device Description

• 2-ply pads • Saturated with 70% isopropyl alcohol • 100 individually packed alcohol pads per box • For external use only

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKB	Pad, Alcohol, Device Disinfectant	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
61694	Skin-cleaning wipe, non-sterile	A non-sterile device consisting of an absorbent fabric pre-soaked in a liquid solution [e.g., with a detergent, alcohol, saline, hyaluronic acid (HA), plant extracts] 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
Package	10860000526583	GS1	Outer Case	50	In Commercial Distribution
Primary	00860000526586	GS1

Customer Contacts

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