Sage

Basic Information

• Brand Name: Sage
• Primary DI: 00618029850591
• Version / Model: 9101
• Catalog Number: 9101
• Company Name: SAGE PRODUCTS, LLC
• Labeler DUNS: 054326178
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-10
• Public Version: 4
• Public Version Date: 2023-11-07
• Public Version Status: Update
• Public Device Record Key: 4971ccf5-113e-4f57-a64e-15266f86ea4e

Device Description

Antiseptic Skin Cleansing Kit with 2% Chlorhexidine Gluconate (CHG)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: Yes
• 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: 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
FRL	FIBER, MEDICAL, ABSORBENT	General Hospital	880.5300	1
MAC	Decontamination kit	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45171	Dry medical towel/wipe, single-use	A dry fabric intended to be used to wipe or dry a patient’s intact skin (not related to wound care), clean medical devices/equipment (e.g., endoscopes, ultrasound systems), and/or clean the general environment (e.g., fluid spill). It may be moistened (e.g., with water or used together with disinfectant/cleaning solutions) however no solutions are included. Some devices may be provided sterile, or designed to be sterilized, for use under sterile conditions [e.g., within an operating room (OR)]; devices intended for non-surgical applications may be provided and used in a non-sterile state. This is a single-use device.	No	Active
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	50618029850596	GS1	case	30	In Commercial Distribution
Primary	00618029850591	GS1

Customer Contacts

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