SafeTrace Tx

GUDID 00812747010033

SafeTrace Tx version 4.x.x

HAEMONETICS CORPORATION

Blood bank information system application software

• Primary Device ID: 00812747010033
• NIH Device Record Key: 11e53386-4ccb-4020-ac7f-a571dbd58289
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeTrace Tx
• Version Model Number: 4.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812747010033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK180209

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: 2019-04-12
• Device Publish Date: 2019-04-04

On-Brand Devices [SafeTrace Tx]

• 00812747010101: SafeTrace Tx version 3.x.x
• 00812747010033: SafeTrace Tx version 4.x.x