RSDL

Basic Information

• Brand Name: RSDL
• Primary DI: 00817129020006
• Version / Model: F5402G
• Company Name: EMERGENT PROTECTIVE PRODUCTS USA INC.
• Labeler DUNS: 079093721
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-02
• Public Version: 2
• Public Version Date: 2023-08-28
• Public Version Status: Update
• Public Device Record Key: fbed5dd1-a444-4887-96cf-c9029d525d97

Device Description

Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents from the skin.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: No
• 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
MAC	Decontamination Kit	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64305	Hazardous chemical decontamination agent, professional	A substance intended for professional use to decontaminate uninjured skin, garments, and/or non-powered devices that have been contaminated by highly-toxic chemical agents (e.g., VX gas, sarin, soman and iperit), typically on the battlefield or in other emergency settings. It consists of inorganic and/or organic compounds available in various forms (e.g., spray, liquid, gel, foam, powder). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817129020000	GS1	Overpack	4	In Commercial Distribution
Package	10817129020003	GS1	Case	60	In Commercial Distribution
Primary	00817129020006	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023969	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius