Animas Vibe 11851500

No FDA recalls on record, checked 23 Oct 2026.

Trade Name

Animas Vibe

Generic Name

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Model / Ref / Catalog

11851500

Primary DI / UDI-DI

10840406100617

FDA Product Code

OYC

GMDN Term

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Device Class

Class III

GUDID distribution status

Not in Commercial Distribution

MRI Safety

MR Unsafe

• Ez Set Infusion Set

  Class II

  FDA 510(k) K012754 Active Cleared 27 Aug 2001

• Ezmanager Max Diabetes Management Software

  Class II

  FDA 510(k) K063674 Active Cleared 30 Mar 2007

• R1000 Series Insulin Pump

  Class II

  FDA 510(k) K993184 Active Cleared 10 Feb 2000

• Model IR 1200 Insulin Pump

  Class II

  FDA 510(k) K032257 Active Cleared 16 Oct 2003

• Ez Manager Max Diabetes Management Software

  Class II

  FDA 510(k) K080587 Active Cleared 15 May 2008

• Symphony Glucose Management System

  Class II

  FDA 510(k) K080639 Active Cleared 24 Jun 2008

See all devices from Animas Corp. →