HeartCare Specimen Collection Kit HTx-00009

GUDID 00860193001723

Convenience Kit for Phlebotomy of blood sample for HeartCare testing

CAREDX, INC.

Phlebotomy kit

• Primary Device ID: 00860193001723
• NIH Device Record Key: 37f30c03-f22e-4467-93f9-33b584014297
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartCare Specimen Collection Kit
• Version Model Number: HTx-00009
• Catalog Number: HTx-00009
• Company DUNS: 102819484
• Company Name: CAREDX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: 415-287-2427
• Email: rramirez@caredx.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *18-25C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860193001723 [Primary]

FDA Product Code

• OFZ: Blood Specimen Collection Kit (Excludes Hiv Testing)

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: 2020-05-08
• Device Publish Date: 2020-04-30

Devices Manufactured by CAREDX, INC.

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• 00860193001730 - KidneyCare Specimen Collection Kit: 2022-11-08 Convenience Kit for Specimen Collection Phlebotomy
• 00860193001747 - KidneyCare Specimen Collection Kit: 2022-11-08 Convenience mobile phlebotomy sample collection kit
• 00860193001709 - AlloSure Specimen Collection Kit: 2020-05-08 Convenience Kit for Phlebotomy kit of blood sample for AlloSure testing
• 00860193001716 - Allomap Specimen Collection Kit: 2020-05-08 Convenience Kit for Phlebotomy of blood sample for AlloMap testing
• 00860193001723 - HeartCare Specimen Collection Kit: 2020-05-08Convenience Kit for Phlebotomy of blood sample for HeartCare testing
• 00860193001723 - HeartCare Specimen Collection Kit: 2020-05-08 Convenience Kit for Phlebotomy of blood sample for HeartCare testing