ReSURGE™ 21521

GUDID D687215211

ReSURGE™ Instrument Cleaning Solution 1L (33.8 oz)

Sultan Healthcare Inc

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