directCHECK ACT-LR Whole Blood Controls, Level 1 000DCGLR-1

GUDID 00711234170369

directCHECK GH100 ACTLRL1 15/box.

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Multiple coagulation factor IVD, control

• Primary Device ID: 00711234170369
• NIH Device Record Key: d31961b1-71ad-4d16-bfb1-9d2668a7cfad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: directCHECK ACT-LR Whole Blood Controls, Level 1
• Version Model Number: 000DCGLR-1
• Catalog Number: 000DCGLR-1
• 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: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.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
• 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
• 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
• 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	00711234170369 [Unit of Use]
GS1	10711234170366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202101

FDA Product Code

• GGN: Plasma, Coagulation Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-21

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• 10711234101094 - Hemochron Whole Blood Coagulation System: 2022-08-31 ACT Tubes 95 tubes/box
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• 10711234101384 - Hemochron Whole Blood Coagulation System: 2022-08-31 Celite ACT Tubes - 95 tubes/box
• 10711234101391 - Hemochron Whole Blood Coagulation System: 2022-08-31 Kaolin ACT Tubes - 95 tubes/box
• 10711234102176 - Hemochron Whole Blood Coagulation System: 2022-08-31 RxDx Whole Blood Quality Control Heparin 40/box