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Na 48409

by Medtronic PS Medical 2 variants

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 Number00643169466319 UDI-DI Date21 Jul 2015ListedStatusListed 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  • Withdrawn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

Generic Name
Subcutaneous tunneller, single-use
Model / Reference
48409
Primary DI / UDI-DI
00643169466319
510(k) Number
FDA Product Code
JXG, MAJ
GMDN Term
Subcutaneous tunneller, single-use
Device Class
Class II
Regulation Number
882.5550, 868.5120
GUDID distribution status
In Commercial Distribution
Size
Length — 60.0 Centimeter

Related devices

Category: Subcutaneous tunneller, single-use

Cleared under the same submission (K911382)

Show all (12)

Other devices from Medtronic PS Medical

See all devices from Medtronic PS Medical →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

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