Palindrome

Primary DI
10884521158115
Brand
Palindrome
Company
Mozarc Medical US LLC
Model
8888145045P
Device description
Precision H Chronic Catheter Kit,Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 28 cm
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
NYUCatheter, hemodialysis, implanted, coated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYUCatheter, Hemodialysis, Implanted, CoatedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123196000PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATHCovidien2013-01-31MSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521158112PackageGS15In Commercial Distribution
10884521158115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452115811220884521158112
1088452115811510884521158115

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableA sterile, 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. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14.5French
Length28Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
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
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
10884521004801MAHURKAR88137930092015-10-22
10884521004832MAHURKAR88137930132015-10-22
10884521004887MAHURKAR88138160092015-10-22
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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
10884521157712PalindromeMozarc Medical US LLCNYU2014-09-22
10884521157781PalindromeMozarc Medical US LLCNYU2014-09-22
10884521157927PalindromeMozarc Medical US LLCNYU2014-09-22
10884521157965PalindromeMozarc Medical US LLCNYU2014-09-22
10884521157828PalindromeMozarc Medical US LLCNYU2014-09-22
10884521157859PalindromeMozarc Medical US LLCNYU2014-09-22
10884521157897PalindromeMozarc Medical US LLCNYU2014-09-22
10884521158061PalindromeMozarc Medical US LLCNYU2014-09-22
10884521158078PalindromeMozarc Medical US LLCNYU2014-09-22
10884521158085PalindromeMozarc Medical US LLCNYU2014-09-22
10884521158092PalindromeMozarc Medical US LLCNYU2014-09-22
10884521158108PalindromeMozarc Medical US LLCNYU2014-09-22
10884521158122PalindromeMozarc Medical US LLCNYU2014-09-22
10884521158139PalindromeMozarc Medical US LLCNYU2014-09-22
10884521056602PalindromeMozarc Medical US LLCNYU2014-09-22
20884521157757PalindromeMozarc Medical US LLCNYU2014-09-22