Hemochron Whole Blood Coagulation System

Basic Information

• Brand Name: Hemochron Whole Blood Coagulation System
• Primary DI: 10711234101094
• Version / Model: P214
• Catalog Number: P214
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Labeler DUNS: 079299318
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 95
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2022-08-31
• Public Version Status: Update
• Public Device Record Key: 7a183fe6-787c-4820-aec1-e6d2e1d0c66f

Device Description

ACT Tubes 95 tubes/box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JBP	Activated Whole Blood Clotting Time	Hematology	864.7140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55994	Activated clotting time (ACT) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the activated clotting time (ACT) of a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10711234101094	GS1
Unit of Use	00711234101097	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius