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Passio Handheld Control Unit PAS-03

by Bearpac Medical, LLC

Passio Handheld Control Unit PAS-03 is a thoracic suction pump (FDA Class II; FDA product code DWM, Apparatus, Suction, Patient Care) made by Bearpac Medical, LLC, listed in FDA GUDID since 7 Jul 2025 (UDI-DI 00860099001315), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860099001315 UDI-DI Date7 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Passio Handheld Control Unit
Generic name
Thoracic suction pump
Model / reference
PAS-03
Primary DI / UDI-DI
00860099001315
FDA product code
DWM
GMDN term
Thoracic suction pump
Device class
Class II
Regulation number
870.5050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DWM (Apparatus, Suction, Patient Care).

Other devices from Bearpac Medical, LLC

See all devices from Bearpac Medical, LLC →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)