Hemochron Whole Blood Coagulation System HR1003

GUDID 10711234540114

Temperature Verification Tube

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered Coagulation analyser IVD, point-of-care, line-powered

• Primary Device ID: 10711234540114
• NIH Device Record Key: dd8c11e7-9af6-496c-aa0b-7273ab50d83e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemochron Whole Blood Coagulation System
• Version Model Number: HR1003
• Catalog Number: HR1003
• Company DUNS: 079299318
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10711234540114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990449

FDA Product Code

• JPA: System, Multipurpose For In Vitro Coagulation Studies

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-09-01
• Device Publish Date: 2016-09-22

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• 10711234102206: ACT Whole Blood Quality Control 40/box
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• 10711234101094: ACT Tubes 95 tubes/box
• 10711234540114: Temperature Verification Tube