ReSURGE™ 21521

GUDID D687215211

ReSURGE™ Instrument Cleaning Solution 1L (33.8 oz)

Sultan Healthcare Inc

Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent

• Primary Device ID: D687215211
• NIH Device Record Key: f7308311-f286-4845-98ca-0863e39968b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReSURGE™
• Version Model Number: 21521
• Catalog Number: 21521
• Company DUNS: 056296981
• Company Name: Sultan Healthcare Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.
• Special Storage Condition, Specify: Between 0 and 0 *May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• Special Storage Condition, Specify: Between 0 and 0 *Causes skin irritation and eye irritation.
• Special Storage Condition, Specify: Between 0 and 0 *See Instructions for Use.
• Special Storage Condition, Specify: Between 0 and 0 *May cause respiratory irritation. In case of inadequate ventilation, wear respiratory protection.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D687215211 [Primary]

FDA Product Code

• FLG: Cleaner, ultrasonic, medical instrument

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: 2022-12-13
• Device Publish Date: 2022-12-05

On-Brand Devices [ReSURGE™ ]

• D687215211: ReSURGE™ Instrument Cleaning Solution 1L (33.8 oz)
• D687215200: ReSURGE™ Instrument Cleaning Solution 24x1/2 oz (14.8 mL) Packets