e-Delphyn Donor

GUDID 00860007282706

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

Gpi Usa, Inc.

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)