Donor-ID

Basic Information

• Brand Name: Donor-ID
• Primary DI: 1928342896382000
• Version / Model: 3.3.5
• Company Name: HEALTHCARE ID, INC.
• Labeler DUNS: 069290125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-14
• Public Version: 1
• Public Version Date: 2025-01-22
• Public Version Status: New
• Public Device Record Key: 0549372c-4376-4df0-98c3-c5256f1d8d14

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMH	Blood Establishment Computer Software And Accessories	Hematology	864.9165	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60065	Configurable electronic form web-based application software	An application software program designed as an Internet-based information system intended to replace paper forms by electronically collecting and recording all types of patient clinical information, investigation results, and treatment data. It is a generic system which can be used in healthcare by configuration of workflows, metadata, and data lifecycles; and by integration into electronic medical record (EMR) systems using standard protocols. The electronic forms are intended to provide predefined workflow, input, search, and display functionalities, typically to manage a particular treatment or condition [e.g., hyposensitization (allergy desensitization), cleft lip].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	1928342896382000	ICCBBA