directCHECK Whole Blood Controls DCJLR-A

GUDID 10711234107089

directCHECK ACT-LR Abnormal 15/box

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control

• Primary Device ID: 10711234107089
• NIH Device Record Key: 8bd37ca6-2390-4d44-9e0d-9c93dd536c6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: directCHECK Whole Blood Controls
• Version Model Number: DCJLR-A
• Catalog Number: DCJLR-A
• Company DUNS: 079299318
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Device Count: 15
• 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: 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 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00711234107082 [Unit of Use]
GS1	10711234107089 [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: 4
• 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