PD Care System

Basic Information

• Brand Name: PD Care System
• Primary DI: 07350149360026
• Version / Model: Version 1.X
• Company Name: PainDrainer AB
• Labeler DUNS: 353268713
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-13
• Public Version: 2
• Public Version Date: 2026-03-05
• Public Version Status: Update
• Public Device Record Key: 4488e285-26bd-4bfe-8f91-86935dd55240
• Distribution End Date: 2026-03-04

Device Description

A digital health software solution designed to support individuals with long lasting pain and facilitate remote monitoring by healthcare professionals.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
OUG	Medical Device Data System	General Hospital	880.6310	1
NXQ	Reminder, Medication	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58884	Self-care monitoring/reporting software	An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350149360026	GS1