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.

Blood bank information system application software

• Primary Device ID: 00817955020003
• NIH Device Record Key: 5388520f-4dd7-45ad-9e6a-a8e3572ac348
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GDS (Grifols Donation System)
• Version Model Number: 1
• Company DUNS: 189578800
• Company Name: BIOMAT USA, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 323-313-3900
• Email: patricia.lopez@grifols.com
• Phone: 323-313-3900
• Email: patricia.lopez@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com
• Phone: 919-316-2156
• Email: marcela.magalhaes@grifols.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817955020003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK180240

FDA Product Code

• MMH: Blood Establishment Computer Software And Accessories

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: 2019-01-31
• Device Publish Date: 2018-12-31

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