Skip to content

Intera Ap-03000H

by Intera Oncology

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850014110147 UDI-DI Date28 Jul 2021ListedStatusListed 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  • Withdrawn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
Intera
Generic name
Implantable intrathecal infusion pump, nonprogrammable
Model / Ref / Catalog
AP-03000H, AP03000H
Primary DI / UDI-DI
00850014110147
FDA product code
LKK
GMDN term
Implantable intrathecal infusion pump, nonprogrammable
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Total Volume — 30 Milliliter

Other devices from Intera Oncology

See all devices from Intera Oncology →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Manufacturing date: No