GDS (Grifols Donation System)

GUDID 00817955020003

GDS (acronym for Grifols Donation System) is an application designed to manage plasma donor center activities such as donor eligibility, unit suitability, shipments (units and samples), and sample management. GDS software provides management controls and information services modules that have been designed to assist personnel in the operational core functions in the company’s plasma donor centers.

BIOMAT USA, INC.

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Primary Device ID00817955020003
NIH Device Record Key5388520f-4dd7-45ad-9e6a-a8e3572ac348
Commercial Distribution StatusIn Commercial Distribution
Brand NameGDS (Grifols Donation System)
Version Model Number1
Company DUNS189578800
Company NameBIOMAT USA, INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone323-313-3900
Emailpatricia.lopez@grifols.com
Phone323-313-3900
Emailpatricia.lopez@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com
Phone919-316-2156
Emailmarcela.magalhaes@grifols.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817955020003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MMHBlood Establishment Computer Software And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-31
Device Publish Date2018-12-31

Devices Manufactured by BIOMAT USA, INC.

00817955020003 - GDS (Grifols Donation System)2019-01-31GDS (acronym for Grifols Donation System) is an application designed to manage plasma donor center activities such as donor eligibility, unit suitability, shipments (units and samples), and sample management. GDS software provides management controls and information services modules that have been designed to assist personnel in the operational core functions in the company’s plasma donor centers.
00817955020003 - GDS (Grifols Donation System)2019-01-31 GDS (acronym for Grifols Donation System) is an application designed to manage plasma donor center activities such as donor elig
00817955020010 - SGP (Plasma Management System)2019-01-31 SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics o

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