ElDorado Donor

GUDID 00812747010132

ElDorado Donor 2.x.x

HAEMONETICS CORPORATION

Blood bank information system application software

• Primary Device ID: 00812747010132
• NIH Device Record Key: 8ce621c7-7e05-4f59-8a9b-776e975282e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ElDorado Donor
• Version Model Number: 2.x.x
• Company DUNS: 057827420
• Company Name: HAEMONETICS CORPORATION
• 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: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812747010132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK070064

FDA Product Code

• MMH: SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-30

On-Brand Devices [ElDorado Donor]

• 00812747010149: ElDorado Donor version 3.x.x
• 00812747010132: ElDorado Donor 2.x.x