Automated Blood Coagulation Analyzer CA-600 series

GUDID 04987562425716

Automated Blood Coagulation Analyzer CA-660

SYSMEX CORPORATION

Coagulation analyser IVD, laboratory, automated

• Primary Device ID: 04987562425716
• NIH Device Record Key: e09975ba-1d4f-42c1-bce5-c41182d08605
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automated Blood Coagulation Analyzer CA-600 series
• Version Model Number: CK978289
• Company DUNS: 690664461
• Company Name: SYSMEX 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: false
• Serial Number: true
• Manufacturing Date: true
• 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
• 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
• Phone: +1(888)879-7639
• Email: crc@sysmex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987562425716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031377

FDA Product Code

• GKP: INSTRUMENT, COAGULATION, AUTOMATED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-18
• Device Publish Date: 2016-08-05

On-Brand Devices [Automated Blood Coagulation Analyzer CA-600 series]

• 04987562425716: Automated Blood Coagulation Analyzer CA-660
• 04987562425686: Automated Blood Coagulation Analyzer CA-620