SoftDonor

GUDID 00859474006175

SCC SOFT COMPUTER

Blood bank information system application software

• Primary Device ID: 00859474006175
• NIH Device Record Key: d5b16d6d-894f-48f2-b5a1-0e35891e203d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoftDonor
• Version Model Number: 4.5.3.1
• Company DUNS: 131311409
• Company Name: SCC SOFT COMPUTER
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859474006175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK080069

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-25

On-Brand Devices [SoftDonor]

• 00859474006175: 4.5.3.1
• 00859474006137: 4.5.4.0
• 00859474006656: 4.5.4.1
• 00810055813650: 4.5.4.2
• 00810055814152: 4.5.5.1