CHRONO-LOG

GUDID 00811476011670

vW CoFactor Opti8 Software

CHRONO-LOG CORP

Platelet aggregation analyser IVD

• Primary Device ID: 00811476011670
• NIH Device Record Key: 96b3d384-e967-43ad-bccb-9c218679bf9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHRONO-LOG
• Version Model Number: vW CoFactor Opti8 Software
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811476011670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940792

FDA Product Code

• JBX: Aggregrometer, Platelet

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: 2023-06-29
• Device Publish Date: 2023-06-21

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