FDA.reportPublic FDA data

BETA BIONICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30190040873019004087BETA BIONICS, INC.1N2026-01-0111 Hughes Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850050080022iLet Bionic Pancreas - iLet Bionic Pancreas (Pharmacy Starter Kit)855-745-3800xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3175981435386173K223846iLet® ACE PumpQFG2023-05-19
3175981599359790K220916iLet® Dosing Decision SoftwareQJI2023-05-19
3175981661457127K173879MiniMed Mio Advance infusion setFPA2018-03-05
3175981204007232K110771BD SINGLE USE, HYPODERMIC SYRINGEFMF2011-05-13
3175981759564350K041545CONTACT DETACHFPA2004-06-30
3175981554122123K032854UNOMEDICAL MONICA INFUSION SETFPA2003-10-09
3175981750807529K021475BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETFMI2002-07-19
3175981082507743

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA32018-03-05
QJI12023-05-19
QFG12023-05-19
FMF12011-05-13
FMI12002-07-19

PMN#

GUDID#