FDA.reportPublic FDA data

FENWAL INTERNATIONAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26489791000222291FENWAL INTERNATIONAL, INC.1N2026-01-01CAMINO REAL INDUSTRIAL PARK, ROAD No. 122 San German PR US 00683
96120513002806457FENWAL INTERNATIONAL, INC.1N2026-01-01CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO ZONA FRANCA Ind. De S.C. HAINA San Cristobal DO --
26275112627511FENWAL INTERNATIONAL, INC.1N2020-04-25RD 357 KM 0.8 MARICAO PR US 00606

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1753741277775605K984586FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRSDTN1999-06-29
1753741000885538K984233C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINECAC1999-02-01
1753741463244018K971274C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SETCAC1997-06-13
1753742057959363K904223SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETSCAK1990-10-26
1753741687706715K871198BONE MARROW COLLECTION KIT AND STANDLWE1987-11-06
1753741366991501K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorFPA2021-11-10
1753741370038278K210089CATSmart, Automated Blood Processing Autotransfusion SystemCAC2021-02-11
1753741202960113K183311Ivenix Infusion System (IIS)FRN2019-06-07
1753741490823893K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterLKN2018-12-04
1753741225803155K141019AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHEDLKN2014-06-10
1753741606928922K111702AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPELKN2012-03-22
1753741933908467K073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORBRZ2008-03-03
1753741465335013BP850001
1753741151997234BK990009
1753741906531970BK980041
1753741358805518BK960083
1753742016889578BK960005
1753741658056828BK940040
1753741236702012BK251289
1753741283128918BK251160
1754181090435355BK230825
1753741213698683BK230824
1753741074145612BK220785
1754181624894733BK200475
1753741070754333BK190421
1753741584548504BK190362
1753741837992694BK180293
1753741739744907BK170030
1754181405681946BK170001
1754181423414796BK160112
1753741423414796BK160112
1753741317190992BK160042
1753741498870149BK160028
1753741360639636BK150357
1753741476242312BK150288
1753741190555128BK150242
1754181108663750BK150236
1754181434141742BK130030
1754181035540947BK120082
1754231035540947BK120082
1753741035540947BK120082
1753742058195729BK120047
1753741028566065BK120041
1754181028566065BK120041
1754231028566065BK120041
1753741747163483BK120018
1753742008876173BK110072
1753741484933399BK110066
1754181934702664BK110030
1754231934702664BK110030
1754181736516165BK100044
1754231736516165BK100044
1753741786761674BK090065
1754181786761674BK090065
1754231786761674BK090065
1753741647926282BK090031
1753741422344364BK080048
1753741996744685BK080033
1753741119448276BK080024
1753741597475296BK080018
1753741016014693BK060061
1754181695017940BK050038
1754231695017940BK050038
1754181756308488BK040059
1754231756308488BK040059
1754181070618302BK030085
1754181811238891BK020059
1754181363736095BK020056
1753741044082309BK020008
1753741202258100BK010033
1753741732290697BK000047
1754231487269382BK000039
1754231079242069
1753741118172977
1753741826604595
1753741010365086
1753741079242069
1754181271993438
1753741316830898
1753741336763273
1753741396656618
1753741611942211
1753741641794311
1753741663838204
1753741677369995
1753741831773964
1753741955056510
1753741991572881

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAC32021-02-11
LKN32018-12-04
BRZ22008-03-03
FPA12021-11-10
FRN12019-06-07
DTN11999-06-29
CAK11990-10-26
LWE11987-11-06