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.

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• 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