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Passio Disposable Collection System PAS-07

by Bearpac Medical, LLC

Passio Disposable Collection System PAS-07 is a pleural/peritoneal drainage catheterization kit (FDA Class II; FDA product code DWM, Apparatus, Suction, Patient Care) made by Bearpac Medical, LLC, cleared under FDA 510(k) K201404 on 20 Nov 2020 and listed in FDA GUDID since 25 Aug 2023 (UDI-DI 00860099001308), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K201404

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860099001308 UDI-DI Date25 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201404 Date20 Nov 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201404 decided 20 Nov 2020 Active
  • FDA GUDID UDI-DI 00860099001308 listed 25 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201404
  2. Listed FDA GUDID 00860099001308

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Passio Disposable Collection System
Generic name
Pleural/peritoneal drainage catheterization kit, non-medicated
Model / reference
PAS-07
Primary DI / UDI-DI
00860099001308
510(k) Number
FDA product code
DWM
GMDN term
Pleural/peritoneal drainage catheterization kit, non-medicated
Device class
Class II
Regulation number
870.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pleural/peritoneal drainage catheterization kit

Cleared under the same submission (K201404)

Similar devices in this category

Other devices filed under Pleural/peritoneal drainage catheterization kit.

Other devices from Bearpac Medical, LLC

See all devices from Bearpac Medical, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)