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K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing PP01X90

by Sb-Kawasumi Laboratories, Inc.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04987488111304 UDI-DI Date31 May 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  • Withdrawn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
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
Generic Name
Vascular port administration set
Model / Ref / Catalog
PP01X90
Primary DI / UDI-DI
04987488111304
FDA Product Code
PTI
GMDN Term
Vascular port administration set
Device Class
Class II
Regulation Number
880.5570
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Needle Gauge — 19 Gauge

Other devices from Sb-Kawasumi Laboratories, Inc.

See all devices from Sb-Kawasumi Laboratories, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No