Chrono-log 490 4+

GUDID 00811476010987

Platelet Aggregometer

CHRONO-LOG CORP

Platelet aggregation analyser IVD, semi-automated

• Primary Device ID: 00811476010987
• NIH Device Record Key: f40625db-153d-4e52-9f5b-7dba1293ed14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chrono-log
• Version Model Number: 490 4+
• Catalog Number: 490 4+
• Company DUNS: 002353696
• Company Name: CHRONO-LOG CORP
• 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: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com
• Phone: 610-853-1130
• Email: chronolog@chronolog.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811476010987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161329

FDA Product Code

• JOZ: System, Automated Platelet Aggregation

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: 2016-12-28

On-Brand Devices [Chrono-log]

• 00811476010994: Platelet Aggregometer
• 00811476010987: Platelet Aggregometer
• 00811476010963: Platelet Aggregometer
• 00811476010956: Platelet Aggregometer
• 00811476010499: Whole Blood Lumi-Aggregometer
• 00811476010482: Whole Blood Lumi-Aggregometer
• 00811476010437: Chrono-log Whole Blood Aggregometer (WBA)
• 00811476010420: Chrono-log Whole Blood Aggregometer (WBA)
• 00811476010413: Chrono-log Whole Blood Aggregometer
• 00811476010406: Chrono-log Whole Blood Aggregometer
• 00811476010390: Chrono-log Whole Blood Aggregometer (WBA)
• 00811476010383: Chrono-log Whole Blood Aggregometer
• 00811476010376: Platelet Aggregometer
• 00811476010369: Platelet Aggregometer
• 00811476010291: vW Reference Plasma Normal
• 00811476010253: Platelet Aggregometer
• 00811476010246: Platelet Aggregometer
• 00811476010161: Ristocetin Cofactor Assay Kit
• 00811476010130: Tris Buffered Saline
• 00811476010123: Lyophilized Human Platelets 6mL, TBS 12mL
• 00811476010017: vW Reference Plasma Deficient
• 00811476010000: Ristocetin 7.5 mg/Vial
• 00811476011670: vW CoFactor Opti8 Software
• 00811476011663: AGGRO/LINK Opti8 Software
• 00811476011045: vW CoFactor Software
• 00811476011021: AGGRO/LINK8 Software
• 00811476011007: AGGRO/LINK WBA Software