FDA.reportPublic FDA data

Palindrome

Primary DI
10884521056602
Brand
Palindrome
Company
Mozarc Medical US LLC
Model
8888123411
Device description
H Chronic Catheter Sport Pack,Symmetrical Tip, Heparin Coating, Pre-Curved Shaft and Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 23 cm
Published
2014-09-22
Public version status
Update
Distribution status
Not 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
NYUCatheter, Hemodialysis, Implanted, Coated

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112477000
K123196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112477000PALINDROME H, SI, HSI CHRONIC CATHETERCovidien2011-09-28NYU
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
20884521056609PackageGS15In Commercial Distribution
10884521056602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452105660920884521056609
1088452105660210884521056602

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
Length23Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.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
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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10801741074490ClampsBard Access Systems, Inc.MSD2016-09-16
10801902126693ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126709ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902126716ARROWTELEFLEX INCORPORATEDMSD2016-09-16
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10801902127195ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127201ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127218ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127225ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127232ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127249ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127256ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127263ARROWTELEFLEX INCORPORATEDMSD2016-09-16
10801902127270ARROWTELEFLEX INCORPORATEDMSD2016-09-16