Caresphere Workflow Solution

GUDID 00664369000851

Sysmex America, Inc.

Clinical laboratory information system application software

• Primary Device ID: 00664369000851
• NIH Device Record Key: 079602fb-7aa3-4538-8004-0a996eb0d5ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caresphere Workflow Solution
• Version Model Number: 1.X
• Company DUNS: 021860424
• Company Name: Sysmex America, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00664369000851 [Primary]

FDA Product Code

• JQP: Calculator/Data Processing Module, For Clinical Use

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: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by Sysmex America, Inc.

• 00664369000851 - Caresphere Workflow Solution: 2022-12-15
• 00664369000851 - Caresphere Workflow Solution: 2022-12-15
• 00664369000639 - Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software: 2018-07-06 Fully Automated Urine Cell Analyzer UF-1000i UF WAM