directCHECK Whole Blood Controls DCJ-005

GUDID 10711234540046

Protective Sleeves

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

• Primary Device ID: 10711234540046
• NIH Device Record Key: d514429f-6729-41ae-a744-b4798cab6871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: directCHECK Whole Blood Controls
• Version Model Number: DCJ-005
• Catalog Number: DCJ-005
• 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: true
• Lot Batch: true
• 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	10711234540046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120977

FDA Product Code

• GGN: Plasma, Coagulation Control

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 [directCHECK Whole Blood Controls]

• 10711234540046: Protective Sleeves
• 10711234170243: directCHECK ACT-LR - Normal 15/box
• 10711234170236: directCHECK PT - Normal 15/box
• 10711234170229: directCHECK ACT+ Normal 15/box
• 10711234170175: directCHECK Citrate APTT - Abnormal 15/box
• 10711234107089: directCHECK ACT-LR Abnormal 15/box
• 10711234107072: directCHECK Citrate PT - Normal 15/box
• 10711234107065: directCHECK Citrate PT - Abnormal 15/box
• 10711234107058: directCHECK ACT+ Abnormal 15/box
• 10711234107041: directCHECK PT - Abnormal 15/box
• 10711234107034: directCHECK APTT - Abnormal 15/box
• 10711234107027: directCHECK APTT- Normal 15/box