SGP (Plasma Management System)

GUDID 00817955020010

SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.

BIOMAT USA, INC.

Blood bank information system application software

• Primary Device ID: 00817955020010
• NIH Device Record Key: 7be1633a-fd01-41f7-8cfc-34fd2be3dcf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SGP (Plasma Management System)
• Version Model Number: 7
• 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	00817955020010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK090082

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): 2019-01-31 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): 2019-01-31SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.
• 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