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InVera Infusion Device

by Invera Medical 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 Number05391547390019 UDI-DI Date9 Oct 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  • Withdrawn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

Generic Name
Peripheral vascular intervention infusion catheter
Model / Ref / Catalog
IMC006 (Shipper label) IMC005 (Carton + Pouch)
Primary DI / UDI-DI
05391547390019
510(k) Number
FDA Product Code
KRA
GMDN Term
Peripheral vascular intervention infusion catheter
Device Class
Class II
Regulation Number
870.1210
GUDID distribution status
In Commercial Distribution

Properties

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