CHRONO-LOG

GUDID 00811476011021

AGGRO/LINK8 Software

CHRONO-LOG CORP

Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD

• Primary Device ID: 00811476011021
• NIH Device Record Key: 9d7060a7-9336-4bd5-9abe-6548d8e59d3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHRONO-LOG
• Version Model Number: AGGRO/LINK8 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811476011021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932566

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