e-Delphyn Donor

GUDID 00860007282706

e-Delphyn Donor version 11.x.x (US)

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: 00860007282706
• NIH Device Record Key: 99fbf1c3-72b4-4bdd-80fc-466b51a38004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-Delphyn Donor
• Version Model Number: 11(US)
• 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	00860007282706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK200515

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: 2021-08-23e-Delphyn Donor version 11.x.x (US)
• 00860007282706 - e-Delphyn Donor: 2021-08-23 e-Delphyn Donor version 11.x.x (US)
• 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)