FDA.reportPublic FDA data

Palindrome

Primary DI
10884521013278
Brand
Palindrome
Company
Mozarc Medical US LLC
Model
8888145048
Device description
HSI Chronic Catheter Kit Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet
Published
2014-09-22
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
MSDCatheter, hemodialysis, implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSDCatheter, Hemodialysis, ImplantedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112477000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112477000PALINDROME H, SI, HSI CHRONIC CATHETERCovidien2011-09-28NYU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521013275PackageGS15In Commercial Distribution
10884521013278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452101327520884521013275
1088452101327810884521013278

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 Gauge14.5French
Device Size Text, specify0
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
Combination product
true
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

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Primary DI, Brand, Company table
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30801902193538ARROWTELEFLEX INCORPORATEDMSD2026-07-22
00884450468913DuraMax®Merit Medical Systems, Inc.MSD2026-07-08
00884450820759CentrosFLO®Merit Medical Systems, Inc.MSD2026-06-25
00884450467572DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450469033BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450469132BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450794760DuraMax®Merit Medical Systems, Inc.MSD2026-06-02
00884908185157MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMedical Components, Inc.MSD2025-11-27
10801902096606ARROWTELEFLEX INCORPORATEDMSD2018-06-26
10801902096620ARROWTELEFLEX INCORPORATEDMSD2018-06-26
10801902096668ARROWTELEFLEX INCORPORATEDMSD2018-06-26
10801741074490ClampsBard Access Systems, Inc.MSD2016-09-16
10801902126693ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126709ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126716ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126723ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126730ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126747ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126754ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126761ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126778ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126785ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126792ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126808ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127157ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127164ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127171ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127188ARROWTELEFLEX INCORPORATEDMSD2016-09-16