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TRANSMEDICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30031524633003152463TRANSMEDICS, INC.1N2026-01-01200 MINUTEMAN RD STE 302 Andover MA US 01810

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
B00912500Organ Care System - OCS Battery9785520900xx@xx.xx
B00944603Solution Delivery Cassettes - 1467978-552-0900xx@xx.xx
B00944670OCS Lung System - OCS Lung Solution9785520900xx@xx.xx
B00950770OCS Liver System - OCS Liver Bile Salts Set978-552-0900xx@xx.xx
B00950840Organ Care System - OCS Battery9785520900xx@xx.xx
B00958753OCS Lung Donor Flush Set - 24069784947494xzhuang@transmedics.com
B00958755OCS Lung Donor Flush Set - 24069784947494xzhuang@transmedics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1639671360137588P200031Organ Care System (OCS™) LiverQQK2021-09-28
1639671996159695P180051Organ Care System (OCS) Heart SystemQIK2021-09-03
1639671454657405P160013Organ Care System (OCS™) Lung SystemQBA2018-03-22
1639671960535566K231362OCS Heart Leukocyte Depleting FilterDTM2023-10-31
1639672009623388K222535OCS Lung Donor Flush SetMSB2022-11-18
1639671423000631K211314OCS Lung SolutionMSB2021-07-29
1639671689164891

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MSB22022-11-18
DTM12023-10-31
QQK 12021-09-28
QIK 12021-09-03
QBA12018-03-22

PMA#

PMN#

GUDID#

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