FDA.reportPublic FDA data

MEDIPINES CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30152726943015272694MEDIPINES CORPORATION1N2026-01-0122755 Savi Ranch Pkwy Ste C Yorba Linda CA US 92887

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
00860001261509MediPines Gas Exchange Monitor - The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.9493984670contact@medipines.com
00860001261516MediPines Single Patient Use Breathing Circuit - Breathing Circuit Kit, Single Patient Use, 109493984670contact@medipines.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2268611836266264K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyCCK2019-01-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CCK12019-01-11

PMN#

GUDID#