FDA device listing

Configurable Manual Batch Entry

FDA device listing 1866595404 · RUBIN & POOR, INC.

Key facts

Proprietary names Configurable Manual Batch Entry
Owner/operator RUBIN & POOR, INC.
Owner/operator number 9044887
Premarket submissions BK030073
Product codes MMH
Device names MMH - Blood Establishment Computer Software And Accessories
Device class Class II
Classification regulations (21 CFR) 864.9165
Review panels Hematology
Registered establishments RUBIN & POOR, INC.
Establishment registrations 2438963
FEI numbers 3003404429
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings