FDA.reportPublic FDA data

PD Care System

Primary DI
07350149360026
Brand
PD Care System
Company
PainDrainer AB
Model
Version 1.X
Device description
A digital health software solution designed to support individuals with long lasting pain and facilitate remote monitoring by healthcare professionals.
Published
2025-11-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NXQReminder, Medication
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXQReminder, MedicationPhysical Medicine1
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350149360026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350149360026073501493600267350149360026

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
353268713
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350149360033PD Care SystemMajor version 22026-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00860008267771Hello Heart Pill BoxHello Heart Inc.NXQ2026-05-06
00860008267788Hello Heart Pill BoxHello Heart Inc.NXQ2026-05-06
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
B553202211OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-04-21
B553202212OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-04-21
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
B553202294OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2026-03-30
B553202295OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2026-03-30
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
B553202311OTC0WelldocWELLDOC, INC.NXQ2026-03-09
B553202312OTC0WelldocWELLDOC, INC.NXQ2026-03-09
B553202313OTC0WelldocWELLDOC, INC.NXQ2026-03-09
07350149360033PD Care SystemPainDrainer ABNXQ2026-03-04
00854073007103VIVI CAP SMARTTempramedNXQ2025-12-09
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2025-11-17
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10