Skip to content

SMARTeZ RS 475070U

by Epic International(Thailand) Company Limited

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 Number18859299150984 UDI-DI Date23 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  • Withdrawn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
SMARTeZ RS
Generic Name
Elastomeric infusion pump system
Model / Reference
475070U
Primary DI / UDI-DI
18859299150984
510(k) Number
FDA Product Code
MEB
GMDN Term
Elastomeric infusion pump system
Device Class
Class II
Regulation Number
880.5725
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250234)

Other devices from Epic International(Thailand) Company Limited

See all devices from Epic International(Thailand) Company Limited →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing 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
  • Expiration Date: No