BIOMAT USA, INC.

Address:13111 Temple Ave.,City of Industry,CA,91746,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Blood Establishment Computer Software And Accessories (MMH) (2)

Premarket Exempt

Clear

GDS (Grifols Donation System) - 00817955020003 Catalog Number :

Device Description : GDS (acronym for Grifols Donation System) is an application designed to manage p 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.

Device Class : 2

Duns Number: 189578800

Premarket Exempt : No

Product Code : MMH

Prescription Use : No

Device Count : 1

SGP (Plasma Management System) - 00817955020010 Catalog Number :

Device Description : SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is a 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.