HeartCare Specimen Collection Kit

Basic Information

• Brand Name: HeartCare Specimen Collection Kit
• Primary DI: 00860193001723
• Version / Model: HTx-00009
• Catalog Number: HTx-00009
• Company Name: CAREDX, INC.
• Labeler DUNS: 102819484
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 1
• Public Version Date: 2020-05-08
• Public Version Status: New
• Public Device Record Key: 37f30c03-f22e-4467-93f9-33b584014297

Device Description

Convenience Kit for Phlebotomy of blood sample for HeartCare testing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
OFZ	Blood Specimen Collection Kit (Excludes Hiv Testing)	Anesthesiology	868.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18026	Phlebotomy kit	A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860193001723	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 18-25C