FDA.reportPublic FDA data

FENWAL INTERNATIONAL, INC.

Matched from indexed company URL: Fenwal, 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
96119023002806589Fenwal France S.A.S.1N2026-01-01Etaille Lacs Indre FR 36400
96120513002806457FENWAL INTERNATIONAL, INC.1N2026-01-01CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO ZONA FRANCA Ind. De S.C. HAINA San Cristobal DO --
30045487763004548776FENWAL, INC.1Y2026-01-013 CORPORATE DR STE 300 LAKE ZURICH IL US 60047
26275112627511FENWAL INTERNATIONAL, INC.1N2020-04-25RD 357 KM 0.8 MARICAO PR US 00606

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
00811137010462NA - SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path1-800-933-6925xx@xx.xx
00811137010486Leukoconnect - LEUKOCONNECT Pre-Storage Sterile Connect Leukoreduction Set with SEPACELL RS-2000 Filter for Red Blood Cells in Additive Solution. Sterile Fluid Path1-800-933-6925xx@xx.xx
00811137010769NA - Red Cell Freezing Pack 2000 mL. Sterile Fluid Path1-800-933-6925xx@xx.xx
10811137010490Transfer Pack - Transfer Pack Container 1000 mL with Coupler. Sterile Fluid Path1-800-933-6925xx@xx.xx
10811137010544Transfer Pack - Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path1-800-933-6925xx@xx.xx
10811137010612Transfer Pack - Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path1-800-933-6925xx@xx.xx
10811137010629Transfer Pack - Quadruple Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path1-800-933-6925xx@xx.xx
20811137010626Transfer Pack - Quadruple Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path1-800-933-6925xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1753631666964000K992275FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TSKDI1999-08-04
1753631277775605K984586FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRSDTN1999-06-29
1753741277775605K984586FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRSDTN1999-06-29
1753631000885538K984233C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINECAC1999-02-01
1753741000885538K984233C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINECAC1999-02-01
1753631999828321K974198TAKY-SPIKE PLUSLHI1997-12-22
1753631787155424K973378C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61CAC1997-11-03
1753631463244018K971274C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SETCAC1997-06-13
1753741463244018K971274C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SETCAC1997-06-13
1753631483466983K961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATORLKN1996-07-31
1753631123218824K960006C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEMCAC1996-07-31
1753632057959363K904223SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETSCAK1990-10-26
1753742057959363K904223SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETSCAK1990-10-26
1753631206380430K895435FRESENIUS AS 104 CELL SEPARATORLKN1990-11-02
1753631687706715K871198BONE MARROW COLLECTION KIT AND STANDLWE1987-11-06
1753741687706715K871198BONE MARROW COLLECTION KIT AND STANDLWE1987-11-06
1753631483276545K830755I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-FPA1983-04-28
1753631961927749K221121Volumat Polyethylene I.V. Administration SetFPA2023-06-16
1753631809783663K220301Volumat LineFPA2023-06-02
1753741366991501K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorFPA2021-11-10
1753631377032239K212445freeflex+ Transfer AdapterLHI2022-06-01
1753631370038278K210089CATSmart, Automated Blood Processing Autotransfusion SystemCAC2021-02-11
1753741370038278K210089CATSmart, Automated Blood Processing Autotransfusion SystemCAC2021-02-11
1753631251520254K200530AMICUS Separator SystemGKT2020-09-11
1753631902906108K192368CATSmartCAC2019-09-27
1753631666878956K192150AMICUS Separator SystemLKN2019-11-13
1753741202960113K183311Ivenix Infusion System (IIS)FRN2019-06-07
1753631116719526K180831CATSmartCAC2018-12-10
1753631490823893K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterLKN2018-12-04
1753741490823893K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterLKN2018-12-04
1753631461767317K162826Encore NeutralFPA2017-06-15
1753631436562947K162462AMICUS Separator System, AMICUS Separator System; RefurbishedGKT2016-11-23
1753631052083267K160735CATSmartCAC2016-09-16
1753631225803155K141019AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHEDLKN2014-06-10
1753741225803155K141019AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHEDLKN2014-06-10
1753631053905989K121613AGILIA INFUSION SYSTEMFRN2013-05-01
1753631606928922K111702AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPELKN2012-03-22
1753741606928922K111702AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPELKN2012-03-22
1753631981242557K092903BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTINGBTA2009-12-01
1753631933908467K073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORBRZ2008-03-03
1753741933908467K073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORBRZ2008-03-03
1753631995920744K060734FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)LKN2006-09-05
1753631200777436K042693IV ADMINISTRATION SET B400 SPFPA2004-10-21
1753632060316092K012178FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAWCAC2001-07-23
1753631294481011K001872I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411FPA2000-09-07
1753631465335013BP850001
1753741465335013BP850001
1788682018963694BP140143
1788681884980771BP130076
1753631151997234BK990009
1753741151997234BK990009
1753631906531970BK980041
1753741906531970BK980041
1753631780303869BK960084
1753631358805518BK960083
1753741358805518BK960083
1753632016889578BK960005
1753742016889578BK960005
1753631005513693BK950035
1753631118172977BK950023
1753631658056828BK940040
1753741658056828BK940040
1753631666719074BK920003
1753631930482919BK880007
1753631758420086BK830009
1753631283128918BK251160
1753741283128918BK251160
1753631017542021BK241135
1753631090435355BK230825
1754181090435355BK230825
1753631213698683BK230824
1753741213698683BK230824
1753631278008680BK220788
1753631074145612BK220785
1753741074145612BK220785
1753631972462941BK200478
1753631624894733BK200475
1754181624894733BK200475
1753631070754333BK190421
1753741070754333BK190421
1753631380265919BK190413
1753631258638614BK190368
1753631584548504BK190362
1753741584548504BK190362
1753632045242275BK190351
1753631837992694BK180293
1753741837992694BK180293
1753631780700915BK180268
1753631892464130BK180254
1753631203598430BK170099
1753631480667983BK170072
1753631404717297BK170057
1753631739744907BK170030
1753741739744907BK170030
1753631405681946BK170001
1754181405681946BK170001
1753631423414796BK160112
1753741423414796BK160112
1754181423414796BK160112
1753631317190992BK160042
1753741317190992BK160042
1753631498870149BK160028
1753741498870149BK160028
1753631715764929BK160012
1753631360639636BK150357
1753741360639636BK150357
1753631476242312BK150288
1753741476242312BK150288
1753631190555128BK150242
1753741190555128BK150242
1753631108663750BK150236
1754181108663750BK150236
1753631434141742BK130030
1754181434141742BK130030
1753631698986145BK130004
1753631035540947BK120082
1753741035540947BK120082
1754181035540947BK120082
1754231035540947BK120082

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAC122021-02-11
LKN102019-11-13
FPA72023-06-16
BRZ32008-03-03
LHI22022-06-01
GKT22020-09-11
FRN22019-06-07
DTN21999-06-29
CAK21990-10-26
LWE21987-11-06
BTA12009-12-01
KDI11999-08-04

NDC#

ACD-A

Fenwal, Inc.

Anticoagulant Citrate Dextrose Solution Formula A

ACD-A

Fenwal, Inc.

Anticoagulant Citrate Dextrose Solution Formula A

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine

CPD/ADSOL

Fenwal, Inc.

anticoagulant citrate phosphate dextrose (cpd) and adsol preservation

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Solution

CPDA-1

Fenwal, Inc.

Anticoagulant Citrate Phosphate Dextrose Adenine

42 records. Showing 1-40. Next

PMA#

PMN#

71 records. Showing 1-40. Next

GUDID#

46 records. Showing 1-40. Next