Hemochron Whole Blood Coagulation System HRS.110-D

GUDID 10711234520062

Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Demonstration)

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

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

• Primary Device ID: 10711234520062
• NIH Device Record Key: 4435c056-95bf-4236-9d2e-2a2616acfcc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemochron Whole Blood Coagulation System
• Version Model Number: HRS.110-D
• Catalog Number: HRS.110-D
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10711234520062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983475

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: 5
• Public Version Date: 2022-08-31
• Device Publish Date: 2016-09-22

On-Brand Devices [Hemochron Whole Blood Coagulation System]

• 10711234540060: Temperature Verification Tube
• 10711234540053: Electronic System Verification Tube
• 10711234540022: Data Manager V3.0
• 10711234520062: Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Demonstration)
• 10711234520055: Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Loaner)
• 10711234520048: Hemochron Whole Blood Coagulation System - Hemochron Response Instrument Refurbished
• 10711234520017: Hemochron Whole Blood Coagulation System - Hemochron Response Instrument
• 10711234202111: Kaolin Protamine Dose Assay - 40 tubes/box
• 10711234202104: Kaolin Protamine Response Test 40 tubes/box
• 10711234202098: Kaolin Protamine Response Test 40 tubes/box
• 10711234202081: Kaolin Heparin Response Test 40 tubes/box
• 10711234202067: Celite Protamine Response Test 40 tubes/box
• 10711234202050: Celite Protamine Response Test 40 tubes/box
• 10711234202036: Heparin Response Test 40 tubes/box
• 10711234102206: ACT Whole Blood Quality Control 40/box
• 10711234102183: RxDx Whole Blood Quality Control Protamine 40/box
• 10711234102176: RxDx Whole Blood Quality Control Heparin 40/box
• 10711234101391: Kaolin ACT Tubes - 95 tubes/box
• 10711234101384: Celite ACT Tubes - 95 tubes/box
• 10711234101230: Celite Protamine Dose Assay - 40 tubes/box
• 10711234101094: ACT Tubes 95 tubes/box
• 10711234540114: Temperature Verification Tube