Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software

GUDID 00664369000639

Fully Automated Urine Cell Analyzer UF-1000i UF WAM

Sysmex America, Inc.

Flow cytometry analyser IVD, automated

• Primary Device ID: 00664369000639
• NIH Device Record Key: 2a99a7ea-493b-4efe-8777-2aba62fc0430
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software
• Version Model Number: UF-1000i with UF WAM
• Company DUNS: 021860424
• Company Name: Sysmex America, 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: false
• Serial Number: true
• 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
• 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
• 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
• 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	00664369000639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080887

FDA Product Code

• LKM: COUNTER, URINE PARTICLE

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: 2016-08-04

Devices Manufactured by Sysmex America, Inc.

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