FDA.reportPublic FDA data

Palindrome non-Precision

Primary DI
10884521135482
Brand
Palindrome non-Precision
Company
Mozarc Medical US LLC
Model
8888541023
Device description
RT Chronic Catheter Kit,Symmetrical Tip, Reverse-Tunneled,15 Fr/Ch (5.0 mm) x 23 cm
Published
2014-09-22
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
MSDCatheter, hemodialysis, implanted

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111817000PALINDROME RT CHRONIC CATHETERCovidien2011-08-30MSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521135489PackageGS15In Commercial Distribution
10884521135482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452113548920884521135489
1088452113548210884521135482

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
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify00Keep away from sunlight.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
Kit
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
10884521004801MAHURKAR88137930092015-10-22
10884521004832MAHURKAR88137930132015-10-22
10884521004887MAHURKAR88138160092015-10-22
10884521004894MAHURKAR88138170052015-10-22
10884521004931MAHURKAR88156680072016-10-13
10884521005006MAHURKAR88171430052015-10-22
10884521005020MAHURKAR88171460012015-10-22
10884521005037MAHURKAR88171460072015-10-22
10884521005150MAHURKAR88304150012015-10-22
10884521005174MAHURKAR88304150032015-10-22
10884521005303MAHURKAR88325390012015-10-22
10884521005341MAHURKAR88325390062015-10-22
20884521004877MAHURKAR88138160052015-10-22
20884521005317MAHURKAR88325390022015-10-22
10884521832930MAHURKAR88156680212022-11-03
10884521832985MAHURKAR88316630212022-11-03
10884521057098MAHURKAR88156680212015-10-22
10884521057234MAHURKAR88316630212015-10-22
10884521811164Ritus88155440102026-04-20
10884521811270Ritus88108050012026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20801902193548ARROWTELEFLEX INCORPORATEDMSD2026-07-23
20801902193593ARROWTELEFLEX INCORPORATEDMSD2026-07-23
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