FDA.reportPublic FDA data

Palindrome

Primary DI
10884521135543
Brand
Palindrome
Company
Mozarc Medical US LLC
Model
8888541123
Device description
RT Repair Kit,Reverse-Tunneled Chronic Catheter Repair,15 Fr/Ch (5.0 mm) x 23 cm
Published
2015-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K092205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092205000PALINDROME P HEMODIALYSIS CATHETERCovidien Lp, Formerly Registered AS Kendall2009-10-30MSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521135543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452113554310884521135543

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15French
Length23Centimeter

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
No natural rubber latex
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
20801902197379ARROWTELEFLEX INCORPORATEDNFK2022-12-08
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