Hemochron Whole Blood Microcoagulation System HE-J04

GUDID 10711234540077

Electronic System Verification Kit

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

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

• Primary Device ID: 10711234540077
• NIH Device Record Key: 93b7a5dd-e179-44cc-bc31-0a2c525f67cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemochron Whole Blood Microcoagulation System
• Version Model Number: HE-J04
• Catalog Number: HE-J04
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10711234540077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020798

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: 2022-08-31
• Device Publish Date: 2016-09-22

On-Brand Devices [Hemochron Whole Blood Microcoagulation System]

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• 10711234510056: Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument (Demonstrat
• 10711234510025: Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument Refurbished
• 10711234510018: Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument
• 10711234540107: Temperature Verification Cartridge
• 10711234540091: Electronic System Verification - Abnormal
• 10711234540084: Electronic System Verification - Normal
• 10711234540077: Electronic System Verification Kit
• 10711234540039: Report Maker V6.01
• 10711234103081: ACT-Low Range Cuvettes - 45 cuvettes/box.
• 10711234103043: Citrate PT Cuvette - 45 test cuvettes/box.
• 10711234103036: PT Cuvette - 45 test cuvettes/box.
• 10711234103029: Citrate APTT Cuvette - 45 test cuvettes/box.
• 10711234103012: APTT Cuvette - 45 test cuvettes/box