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BladeClear BCS-01

by Pathway Medtech, LLC.

BladeClear BCS-01 is a Class I device made by Pathway Medtech, LLC., listed in FDA GUDID since 4 Nov 2024 (UDI-DI 00860012804412), 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 Number00860012804412 UDI-DI Date4 Nov 2024ListedStatusListed 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  • Withdrawn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
BladeClear
Generic name
Luminal device flushing tubing set, single-use
Model / Ref / Catalog
BCS-01
Primary DI / UDI-DI
00860012804412
FDA product code
KGZ
GMDN term
Luminal device flushing tubing set, single-use
Device class
Class I
Regulation number
878.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Luminal device flushing tubing set, single-use

Similar devices

Other devices filed under FDA product code KGZ (Accessories, Catheter).

Other devices from Pathway Medtech, LLC.

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)