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PD Care System Major version 2

by PainDrainer AB

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350149360033 UDI-DI Date4 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PD Care System
Generic Name
Self-care monitoring/reporting software
Model / Reference
Major version 2
Primary DI / UDI-DI
07350149360033
FDA Product Code
OUG, NXQ
GMDN Term
Self-care monitoring/reporting software
Device Class
Class I
Regulation Number
880.6310, 890.5050
GUDID distribution status
In Commercial Distribution

Other devices from PainDrainer AB

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No