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Flexi-Port 68360

by Portal Access, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860014030819 UDI-DI Date5 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Flexi-Port
Generic Name
Vascular port/catheter
Model / Ref / Catalog
68360
Primary DI / UDI-DI
00860014030819
510(k) Number
FDA Product Code
LJT
GMDN Term
Vascular port/catheter
Device Class
Class II
Regulation Number
880.5965
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Catheter Length — 46 Centimeter
Catheter Gauge — 6 French

Related devices

Cleared under the same submission (K260916)

Other devices from Portal Access, Inc.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No