Peracidin® 081894

GUDID 20898021000383

Dialyzer Reprocessing Concentrate and RO Disinfectant

Angelini Pharma Inc.

Organic peroxy acid device sterilant, single-use

• Primary Device ID: 20898021000383
• NIH Device Record Key: 46d4d1b8-a627-467b-b0d5-257e7775aefa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peracidin®
• Version Model Number: Gallon
• Catalog Number: 081894
• Company DUNS: 078843940
• Company Name: Angelini Pharma Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: true

Customer Support Contacts

• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com
• Phone: 1-800-726-2308
• Email: CustomerService@Angelini-US.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Explosive pressure rupture of the container can occur if not properly vented.
• Special Storage Condition, Specify: Between 0 and 0 *Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
• Special Storage Condition, Specify: Between 0 and 0 *Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00898021000389 [Primary]
GS1	20898021000383 [Package]; Contains: 00898021000389; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962959

FDA Product Code

• MED: Sterilant, Medical Devices

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: 2024-04-01
• Device Publish Date: 2024-03-22

On-Brand Devices [Peracidin®]

• 00898021000419: Dialyzer Reprocessing Concentrate and RO Disinfectant
• 20898021000406: Dialyzer Reprocessing Concentrate and RO Disinfectant
• 20898021000383: Dialyzer Reprocessing Concentrate and RO Disinfectant