FDA.reportPublic FDA data

MEDELA LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14199371419937MEDELA LLC1Y2026-01-011101 CORPORATE DR. MCHENRY IL US 60050

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
00020451903873Motion InBra™ - YM-88011-800-435-8316customer.service@medela.com
00020451903880Motion InBra™ - YM-88011-800-435-8316customer.service@medela.com
00020451904870Freestyle™ Mini Hands-free - 1010483951-800-435-8316customer.service@medela.com
01220000280335Motion InBra™ Double Pumping set - 1010476011-800-435-8316customer.service@medela.com
01220000280342Motion InBra™ Single Pumping set - 1010476021-800-435-8316customer.service@medela.com
01220000280731Motion InBra™ Double Pumping set - 1010476011-800-435-8316customer.service@medela.com
01220000280748Motion InBra™ Single Pumping set - 1010476021-800-435-8316customer.service@medela.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
108012037533423K962612BILIBED PHOTOTHERAPY LAMPLBI1996-12-12
108011512209031K895367INTRAVENOUS EXTENSION SETFPA1989-10-06
108011308488511K894206INTOPOFMF1989-10-27
108011815885526K875300MEDELA BREAST-PUMP LACTINAHGX1988-04-06
108011308229883K853176CANNON BABYSAFE NIPPLE SHIELDSHFS1985-08-22
108011763577352K844297SUPPLEMENTAL FEEDING SYSTEMHGY1985-02-25
108011905992611K823840MEDELA NAMUAL BREAST PUMPHGY1983-01-24
108011271690145K253510Freestyle Mini Hands-freeHGX2026-04-10
108011889571089K253498Pump In Style® Pro+HGX2026-01-22
108011876116691K253149Motion InBra (YM-8801) wearable breast pumpHGX2026-02-13
108011237008800K232608Duo Hands-free Breast PumpHGX2024-04-12
108011595446582K210759Solo, Swing MaxiHGX2021-08-11
108012000946333K200508Pump In StyleHGX2020-06-15
108011122472554K181937Pump In Style Advanced, Advanced Personal Double BreastpumpHGX2018-10-16
108011309766959K162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)PNR2016-09-22
108011626009319K161811Medela Low Dose Enteral SyringePNR2017-02-15
108011436635251K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailHGX2016-10-28
108011737188223K122449ENTERAL NUTRITION WARMERLGZ2013-06-13
108011818561231K092986ACACIA PISTON SYRINGEFMF2009-10-27
108011649834855K080328MPS ACACIA ENTERAL FEEDING TUBEKNT2008-05-14
108011087951042K061435MEDELA VARIO SUCTION PUMPSOMP2006-06-08
108011113614271K061205MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATORBTA2006-06-21
108011028760283K053052MEDELA SWING BREAST PUMPHGX2006-05-02
108011757139641K033179MEDELA CLARIO HOME CARE PUMPBTA2003-10-15
108011259218008K031614MEDELA PUMP IN STYLE ADVANCED BREAST PUMPHGX2003-06-06
108011570064794K021368MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057BTA2002-05-15
108011437177616K020518MEDELA SYMPHONY BREAST PUMP, MODEL 024HGX2002-03-07
108011065414110
108011152202255
108011160520066
108011215396389
108011302796302
108011334293008
108011440940373
108011473364849
108011486719998
108011620947603
108011775220499
108011858262235
108011984715563

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HGX122026-04-10
BTA32006-06-21
PNR22017-02-15
FMF22009-10-27
HGY21985-02-25
LGZ12013-06-13
KNT12008-05-14
OMP12006-06-08
LBI11996-12-12
FPA11989-10-06
HFS11985-08-22

PMN#

GUDID#

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