PD Care System

GUDID 07350149360026

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

PainDrainer AB

Self-care monitoring/reporting software
Primary Device ID07350149360026
NIH Device Record Key4488e285-26bd-4bfe-8f91-86935dd55240
Commercial Distribution StatusIn Commercial Distribution
Brand NamePD Care System
Version Model NumberVersion 1.X
Company DUNS353268713
Company NamePainDrainer AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS107350149360026 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-21
Device Publish Date2025-11-13

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