FDA.reportPublic FDA data

NA

Primary DI
10884521056282
Brand
NA
Company
Mozarc Medical US LLC
Model
8888200001
Device description
Acute and Chronic Catheter Repair Kit,Palindrome Chronic Care and all MAHURKAR Acute and Chronic Care Catheters
Published
2015-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFKKit, repair, catheter, hemodialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFKKit, Repair, Catheter, HemodialysisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092797000ACUTE AND CHRONIC CATHETER REPAIR KITKendall2009-11-19NFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521056282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452105628210884521056282

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableAn implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com
+39053529111RegulatoryOperations@mozarcmedical.com

Regulatory Flags#

DUNS number
118997146
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521811164Ritus88155440102026-04-20
10884521811270Ritus88108050012026-04-20
10884521811287Ritus88137910012026-04-20
10884521811201Ritus88177910012024-10-21
10884521852822Argyle88884114472026-02-06
10884521005471MAHURKAR88881351662015-08-31
10884521006287MAHURKAR88881351342015-08-31
10884521006300MAHURKAR88881351352015-08-31
10884521006324MAHURKAR88881351362015-08-31
10884521006386MAHURKAR88881351632015-08-31
10884521006409MAHURKAR88881351642015-08-31
10884521006423MAHURKAR88881351652015-08-31
10884521006492MAHURKAR88881351932015-08-31
10884521006508MAHURKAR88881351942015-08-31
10884521006522MAHURKAR88881351962015-08-31
10884521006553MAHURKAR88881352432015-08-31
10884521006560MAHURKAR88881352442015-08-31
10884521070332Argyle88311730102015-10-22
10884521794733MAHURKAR88172320192020-04-12
10884521794740MAHURKAR88311730102020-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902197372ARROWTELEFLEX INCORPORATEDNFK2022-12-08
20801902197355ARROWTELEFLEX INCORPORATEDNFK2022-12-02
30801902197352ARROWTELEFLEX INCORPORATEDNFK2022-12-02
20801902197409ARROWTELEFLEX INCORPORATEDNFK2022-12-01
20801902197461ARROWTELEFLEX INCORPORATEDNFK2022-12-01
20801902197485ARROWTELEFLEX INCORPORATEDNFK2022-12-01
10801902197402ARROWTELEFLEX INCORPORATEDNFK2022-12-01
30801902197468ARROWTELEFLEX INCORPORATEDNFK2022-12-01
10801902197488ARROWTELEFLEX INCORPORATEDNFK2022-12-01
20801902195337ARROWTELEFLEX INCORPORATEDNFK2022-11-15
20801902196723ARROWTELEFLEX INCORPORATEDNFK2022-11-15
30801902195334ARROWTELEFLEX INCORPORATEDNFK2022-11-15
30801902196720ARROWTELEFLEX INCORPORATEDNFK2022-11-15
20801902195238ARROWTELEFLEX INCORPORATEDNFK2022-11-11
30801902195235ARROWTELEFLEX INCORPORATEDNFK2022-11-11
20801902197423ARROWTELEFLEX INCORPORATEDNFK2022-11-09
10801902197426ARROWTELEFLEX INCORPORATEDNFK2022-11-09
00884908158205CATHETER REPAIR KITMedical Components, Inc.NFK2020-11-26
30884908158206CATHETER REPAIR KITMedical Components, Inc.NFK2020-11-26
00884908146042N/AMedical Components, Inc.NFK2019-09-05
30884908146043N/AMedical Components, Inc.NFK2019-09-05
00801741045080Catheter Repair KitBard Access Systems, Inc.NFK2017-05-29
10801741045087Catheter Repair KitBard Access Systems, Inc.NFK2017-05-29
00801741045103Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
00801741045110RetrO Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
20801741045107Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
20801741045114RetrO Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
00884908039658CATHETER REPAIR KITMedical Components, Inc.NFK2015-10-24
00884908039856REPAIR KITMedical Components, Inc.NFK2015-10-23