CHRONO-PAR

GUDID 00811476010062

ATP

CHRONO-LOG CORP

Platelet aggregation study IVD, reagent

• Primary Device ID: 00811476010062
• NIH Device Record Key: 780c58f1-33e1-47ac-a06c-bfd12e0c6a38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHRONO-PAR
• Version Model Number: 387
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811476010062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922800

FDA Product Code

• GHR: Reagent, 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: 2016-10-11

On-Brand Devices [CHRONO-PAR]

• 00811476010307: Epinephrine
• 00811476010154: Arachidonic Acid
• 00811476010147: Thrombin
• 00811476010086: Ristocetin
• 00811476010079: CHRONO-LUME
• 00811476010062: ATP
• 00811476010055: Collagen
• 00811476010048: ADP