Chrono-log

GUDID 00811476010017

vW Reference Plasma Deficient

CHRONO-LOG CORP

Platelet aggregation study IVD, reagent

• Primary Device ID: 00811476010017
• NIH Device Record Key: 732d191c-fa6d-4e8f-ac48-db2d75d9aa32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chrono-log
• Version Model Number: 299-4
• 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: 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811476010017 [Primary]
GS1	00811476011212 [Package]; Package: [3 Units]; In Commercial Distribution
GS1	00811476011229 [Package]; Package: [4 Units]; In Commercial Distribution
GS1	00811476011236 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	00811476011243 [Package]; Package: [6 Units]; In Commercial Distribution
GS1	00811476011250 [Package]; Package: [7 Units]; In Commercial Distribution
GS1	00811476011267 [Package]; Package: [8 Units]; In Commercial Distribution
GS1	00811476011274 [Package]; Package: [2 Units]; In Commercial Distribution
GS1	811476010932 [Package]; Package: [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945414

FDA Product Code

• GGP: Test, Qualitative And Quantitative Factor Deficiency

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: 2019-09-06
• Device Publish Date: 2016-10-11

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