AMICUS Separator 6R4590TH-M

GUDID 00810020440249

The AMICUS Separator is an automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.

Fresenius Kabi AG

Apheresis system

• Primary Device ID: 00810020440249
• NIH Device Record Key: ac38ac41-eb83-417c-ab29-305cc526325f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMICUS Separator
• Version Model Number: 6R4590TH-M
• Catalog Number: 6R4590TH-M
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
• Special Storage Condition, Specify: Between 0 and 0 *Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between
• Special Storage Condition, Specify: Between 0 and 0 *0° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810020440249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200530

FDA Product Code

• GKT: Separator, Automated, Blood Cell, Diagnostic

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: 2021-02-17
• Device Publish Date: 2021-02-09

On-Brand Devices [AMICUS Separator]

• 04086000100137: Automated blood cell separator indicated for the collection of blood components and in therapeut
• 04086000100120: Automated blood cell separator indicated for the collection of blood components and in therapeut
• 00810020440232: The AMICUS Separator is an automated blood cell separator indicated for the collection of blood
• 00810020440249: The AMICUS Separator is an automated blood cell separator indicated for the collection of blood
• 00810020440218: The AMICUS Separator is an automated blood cell separator indicated for the collection of blood