Amicus Separator 6R4590R

GUDID 00811137013104

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: 00811137013104
• NIH Device Record Key: 0f019f74-0dc3-42c4-bd39-88ca9de9aef4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amicus Separator
• Version Model Number: 6R4590R
• Catalog Number: 6R4590R
• 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

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Special Storage Condition, Specify: Between 0 and 0 *Fragile equipment
• Special Storage Condition, Specify: Between 0 and 0 *Explosive material
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *This way up
• Special Storage Condition, Specify: Between 0 and 0 *No Pushing
• Special Storage Condition, Specify: Between 0 and 0 *No degree of protection against ingress of water
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Special Storage Condition, Specify: Between 0 and 0 *Fragile equipment
• Special Storage Condition, Specify: Between 0 and 0 *Explosive material
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *This way up
• Special Storage Condition, Specify: Between 0 and 0 *No Pushing
• Special Storage Condition, Specify: Between 0 and 0 *No degree of protection against ingress of water
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Special Storage Condition, Specify: Between 0 and 0 *Fragile equipment
• Special Storage Condition, Specify: Between 0 and 0 *Explosive material
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *This way up
• Special Storage Condition, Specify: Between 0 and 0 *No Pushing
• Special Storage Condition, Specify: Between 0 and 0 *No degree of protection against ingress of water
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Special Storage Condition, Specify: Between 0 and 0 *Fragile equipment
• Special Storage Condition, Specify: Between 0 and 0 *Explosive material
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *This way up
• Special Storage Condition, Specify: Between 0 and 0 *No Pushing
• Special Storage Condition, Specify: Between 0 and 0 *No degree of protection against ingress of water
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Special Storage Condition, Specify: Between 0 and 0 *Fragile equipment
• Special Storage Condition, Specify: Between 0 and 0 *Explosive material
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *This way up
• Special Storage Condition, Specify: Between 0 and 0 *No Pushing
• Special Storage Condition, Specify: Between 0 and 0 *No degree of protection against ingress of water
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Special Storage Condition, Specify: Between 0 and 0 *Fragile equipment
• Special Storage Condition, Specify: Between 0 and 0 *Explosive material
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *This way up
• Special Storage Condition, Specify: Between 0 and 0 *No Pushing
• Special Storage Condition, Specify: Between 0 and 0 *No degree of protection against ingress of water
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Special Storage Condition, Specify: Between 0 and 0 *Fragile equipment
• Special Storage Condition, Specify: Between 0 and 0 *Explosive material
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *This way up
• Special Storage Condition, Specify: Between 0 and 0 *No Pushing
• Special Storage Condition, Specify: Between 0 and 0 *No degree of protection against ingress of water
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Special Storage Condition, Specify: Between 0 and 0 *Fragile equipment
• Special Storage Condition, Specify: Between 0 and 0 *Explosive material
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *This way up
• Special Storage Condition, Specify: Between 0 and 0 *No Pushing
• Special Storage Condition, Specify: Between 0 and 0 *No degree of protection against ingress of water

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811137013104 [Primary]

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: 2026-03-19
• Device Publish Date: 2026-03-11

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
• 00811137013104: The Amicus Separator is an automated blood cell separator indicated for the collection of blood