ElDorado Donor 3.x.x

GUDID 00860007282713

ElDorado Donor 3.x.x

Gpi Usa, Inc.

Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system

• Primary Device ID: 00860007282713
• NIH Device Record Key: ee3a48c0-13ab-4c37-9b4c-c131bb938d5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ElDorado Donor 3.x.x
• Version Model Number: 3.x.x
• Company DUNS: 117765002
• Company Name: Gpi 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-996-8388
• Email: support@gpiusa.com
• Phone: 866-996-8388
• Email: support@gpiusa.com
• Phone: 866-996-8388
• Email: support@gpiusa.com
• Phone: 866-996-8388
• Email: support@gpiusa.com
• Phone: 866-996-8388
• Email: support@gpiusa.com
• Phone: 866-996-8388
• Email: support@gpiusa.com
• Phone: 866-996-8388
• Email: support@gpiusa.com
• Phone: 866-996-8388
• Email: support@gpiusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812747010149 [Previous]
GS1	00860007282713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK150308

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: 2021-08-23
• Device Publish Date: 2021-08-13

Devices Manufactured by Gpi Usa, Inc.

• 00860007282706 - e-Delphyn Donor: 2021-08-23 e-Delphyn Donor version 11.x.x (US)
• 00860007282713 - ElDorado Donor 3.x.x: 2021-08-23ElDorado Donor 3.x.x
• 00860007282713 - ElDorado Donor 3.x.x: 2021-08-23 ElDorado Donor 3.x.x
• 00860007282720 - Donor Doc 3.x.x: 2021-08-23 Donor Doc 3.x.x
• 00860007282737 - Surround 5.x: 2021-08-23 Surround 5.x
• 00860007282744 - e-Delphyn LIS Donor: 2021-08-23 e-Delphyn LIS Donor 11.x.x (US)