Hemochron Whole Blood Coagulation System P214

GUDID 10711234101094

ACT Tubes 95 tubes/box

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent Activated clotting time (ACT) IVD, reagent

• Primary Device ID: 10711234101094
• NIH Device Record Key: 7a183fe6-787c-4820-aec1-e6d2e1d0c66f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemochron Whole Blood Coagulation System
• Version Model Number: P214
• Catalog Number: P214
• Company DUNS: 079299318
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Device Count: 95
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00711234101097 [Unit of Use]
GS1	10711234101094 [Primary]

FDA Product Code

• JBP: Activated Whole Blood Clotting Time

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

On-Brand Devices [Hemochron Whole Blood Coagulation System]

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• 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
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• 10711234202104: Kaolin Protamine Response Test 40 tubes/box
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• 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