Surgicutt Bleeding Time Device SU50I

GUDID 20711234304157

Surgicutt Bleeding Time Device 50/box

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Blood lancet, single-use

• Primary Device ID: 20711234304157
• NIH Device Record Key: ad5eb7cd-5641-420d-8761-4134950c8b1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgicutt Bleeding Time Device
• Version Model Number: SU50I
• Catalog Number: SU50I
• Company DUNS: 079299318
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Device Count: 50
• 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: 1-800-678-0710
• 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
• 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
• 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 Dimensions

• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter
• Length: 5 Millimeter
• Depth: 1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00711234304153 [Unit of Use]
GS1	20711234304157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850542

FDA Product Code

• JCA: Device, Bleeding Time

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-19
• Device Publish Date: 2016-09-22

Devices Manufactured by ACCRIVA DIAGNOSTICS HOLDINGS, INC.

• 10711234515044 - GEM Hemochron 100 System: 2022-10-14 GEM Hemochron 100 System (Loaner)
• 10711234530153 - Avoximeter Whole Blood Oximeter: 2022-09-01 Avoximeter Whole Blood Oximeter System - Instrument (Demonstration)
• 10711234540114 - Hemochron Whole Blood Coagulation System: 2022-09-01 Temperature Verification Tube
• 10711234101094 - Hemochron Whole Blood Coagulation System: 2022-08-31 ACT Tubes 95 tubes/box
• 10711234101230 - Hemochron Whole Blood Coagulation System: 2022-08-31 Celite Protamine Dose Assay - 40 tubes/box
• 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