RSDL

GUDID 20817129020000

EMERGENT PROTECTIVE PRODUCTS USA INC.

Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional Hazardous chemical decontamination agent, professional

• Primary Device ID: 20817129020000
• NIH Device Record Key: fbed5dd1-a444-4887-96cf-c9029d525d97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RSDL
• Version Model Number: F5402G
• Company DUNS: 079093721
• Company Name: EMERGENT PROTECTIVE PRODUCTS USA INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com
• Phone: 1-888-773-3266
• Email: MedicalInformation@ebsi.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817129020006 [Primary]
GS1	10817129020003 [Package]; Contains: 00817129020006; Package: Case [60 Units]; In Commercial Distribution
GS1	20817129020000 [Package]; Contains: 10817129020003; Package: Overpack [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023969

FDA Product Code

• MAC: Decontamination Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-10
• Device Publish Date: 2019-12-02

On-Brand Devices [RSDL]

• 10817129020089: 4002174
• 10817129020010: F5408ENG
• 20817129020000: F5402G