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TriNav Advance Infusion System ADV-38095-50

by Surefire Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857136004408 UDI-DI Date24 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TriNav Advance Infusion System
Generic Name
Peripheral vascular intervention infusion catheter
Model / Reference
ADV-38095-50
Primary DI / UDI-DI
00857136004408
510(k) Number
FDA Product Code
KRA, DQO
GMDN Term
Peripheral vascular intervention infusion catheter
Device Class
Class II
Regulation Number
870.1210, 870.1200
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Catheter Inner Diameter — 0.038 Inch
Catheter Working Length — 95 Centimeter
Catheter Gauge — 4.1 French

Related devices

Cleared under the same submission (K253509)

Other devices from Surefire Medical, Inc.

See all devices from Surefire Medical, Inc. →

Properties

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

Other properties (9)

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