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 Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system
Primary Device ID00810020440249
NIH Device Record Keyac38ac41-eb83-417c-ab29-305cc526325f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMICUS Separator
Version Model Number6R4590TH-M
Catalog Number6R4590TH-M
Company DUNS315654579
Company NameFresenius Kabi AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 AgencyDevice ID
GS100810020440249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKTSeparator, Automated, Blood Cell, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-17
Device Publish Date2021-02-09

On-Brand Devices [AMICUS Separator]

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

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