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MOZARC MEDICAL US LLC

Matched from indexed company URL: Mozarc Medical US LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30305747053030574705MOZARC MEDICAL US LLC1Y2026-01-0115 Hampshire Street Mansfield MA US 02048

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
10884521005471MAHURKAR - Acute Dual Lumen Catheter Tray,High Flow Pre-Curved with IC Components+39053529111RegulatoryOperations@mozarcmedical.com
10884521006287MAHURKAR - Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Components+39053529111RegulatoryOperations@mozarcmedical.com
10884521006300MAHURKAR - Acute Dual Lumen Catheter Tray,High Flow Curved Extensions with IC Components+39053529111RegulatoryOperations@mozarcmedical.com
10884521811164Ritus - Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,16 Fr/Ch (5.3 mm)+39053529111RegulatoryOperations@mozarcmedical.com
10884521811201Ritus - Peritoneal Dialysis Accessory Blunt Tunneling Stylet+39053529111RegulatoryOperations@mozarcmedical.com
10884521811270Ritus - Peritoneal Dialysis Accessory,Beta-Cap Clamp+39053529111RegulatoryOperations@mozarcmedical.com
10884521811287Ritus - Chronic Catheter Accessory,Injection Sealing Cap+39053529111RegulatoryOperations@mozarcmedical.com
10884521852822Argyle - Peritoneal Dialysis Catheter, Tenckhoff, 2 Cuffs+39053529111RegulatoryOperations@mozarcmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3294091721135906K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSMSD1998-11-25
3294091360217830K950042SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETERFJS1995-12-15
3294091351499049K943349MAHURKAR DUAL LUMEN CATHETERFOZ1995-03-22
3294091738095457K920515INSERTIONFJS1992-05-04
3294091625829612K910787TITANIUM CONNECTOR (2 PART)FKO1991-08-15
3294091459712792K910786TROCAR (FALLER STYLET)FJS1991-09-19
3294091199264821K910785TITANIUM CATHETER EXTENDERFJS1991-08-22
3294092040970575K896252MODIFIED QUINTON SINGLE LUMEN CATHETERMPB1990-01-29
3294091555858501K890288PERITONEAL CATHETERS WITH AN ADDED FUNCTIONFJS1989-03-27
3294091895685956K874633PERMCATH INSERTION TRAYLFJ1988-02-17
3294091851142332K873727PULL-APART INTRODUCER (SHEATH)DYB1987-10-07
3294091793903764K873394OVAL PULL-APART SHEATH/DILATORDYB1987-09-30
3294092058902168K871942PERM-CATH CATHETER KITLFJ1987-06-17
3294091334000423K871749ADULT PERM-CATH 40CM.LFJ1987-06-17
3294091500072469K871730MODIFIED USE OF PULL-APART INTRODUCER SETFKO1987-05-18
3294091353667189K862288MODIFICATION OF TISSUE DILATORDRE1986-08-19
3294091588600531K862046SWAN-NECK PERITONEAL DIALYSIS CATHETERSFJS1986-06-19
3294091716496624K850214STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM INFJS1985-07-26
3294091363934134K844692PEDIATRIC SIZED HEMOCATH CATHETERFIQ1985-01-18
3294091734725448K844193QUINTON INJECTION SEALING CAPFOZ1985-05-17
3294091797787544K840815LUER LOCKING ADAPTER(MATERIAL CHANGE)FOZ1984-11-08
3294091016522467K840424HEMOCATH REPAIR KITKNZ1984-03-05
3294091078640624K840415HEMOCATHFIQ1984-04-20
3294091229180031K813488CATHETER REGULARFJS1981-12-31
3294091031585959K780449BETA CAP SYSTEMFJS1978-05-16
3294091077217753K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
3294091194727723K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitFJS2022-01-14
3294091457519256K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterMPB2020-01-17
3294091046400565K180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter ExtenderFJS2018-07-27
3294091967876882K170635Chameleon PTA Balloon CatheterLIT2017-03-30
3294091779934380K163231Chameleon PTA Balloon CatheterLIT2017-01-17
3294091447552137K151678Chameleon PTA Balloon CatheterLIT2015-09-21
3294091823241818K123196PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATHMSD2013-01-31
3294091563431696K121848SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CMMSD2012-09-21
3294091012763084K120674MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETERMPB2012-04-04
3294091346428272K112477PALINDROME H, SI, HSI CHRONIC CATHETERNYU2011-09-28
3294091214481280K111817PALINDROME RT CHRONIC CATHETERMSD2011-08-30
3294091940617752K111372TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...MSD2011-08-04
3294091438690395K102605MAHURKAR TRIPLE LUMEN DIALYSIS CATHETERNIE2010-12-22
3294091826280315K092797ACUTE AND CHRONIC CATHETER REPAIR KITNFK2009-11-19
3294091295568449K092205PALINDROME P HEMODIALYSIS CATHETERMSD2009-10-30
3294092033456494K041006TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FRMSD2004-05-19
3294092069724671K030209MAHURKAR OPLUS CATHETER, MODEL 13.5 FRMPB2003-05-13
3294091054175355K020089MAHURKAR TRIPLE LUMEN CATHETER, 12 FRNIE2002-04-10
3294091254233647K002902TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERSMSD2001-04-09
3294091538811800

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FJS112022-01-14
MSD82013-01-31
MPB42020-01-17
LIT32017-03-30
FOZ31995-03-22
LFJ31988-02-17
NIE22010-12-22
FKO21991-08-15
DYB21987-10-07
FIQ21985-01-18
NYU12011-09-28
NFK12009-11-19
DRE11986-08-19
KNZ11984-03-05
DQX11977-06-14

GUDID#

200 records. Showing 1-40. Next