FDA.reportPublic FDA data

MAHURKAR

Primary DI
10884521057012
Brand
MAHURKAR
Company
Mozarc Medical US LLC
Model
8888340629
Device description
Acute Triple Lumen Catheter Kit,Straight Extensions
Published
2016-09-24
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
NIECATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIECatheter, Hemodialysis, Triple Lumen, Non-ImplantedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020089000
K192302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020089000MAHURKAR TRIPLE LUMEN CATHETER, 12 FRThe Kendall Company2002-04-10NIE
K192302000Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC2020-01-17MPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521057019PackageGS15In Commercial Distribution
10884521057012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452105701920884521057019
1088452105701210884521057012

GMDN Terms#

Term, Definition table
TermDefinition
Triple-lumen haemodialysis catheterA sterile, flexible, triple-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access to: 1) conduct blood from a patient and return it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enable central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes three lumens, two dedicated to coaxial flow of blood for dialysis, and the third intended for independent IV access. Devices dedicated to catheter introduction/function may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length20Centimeter

Contacts#

Phone, Email table
PhoneEmail
+39053529111RegulatoryOperations@mozarcmedical.com

Regulatory Flags#

DUNS number
118997146
Device count
1
Lot or batch
true
Expiration date on label
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
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00801741238093PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238109PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238116PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238130PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238147PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238253Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238260Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238277Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238284Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238291Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238307Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238314Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238321Power-TrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238413PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238420PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238437PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238444PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238451PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238468PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238475PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
00801741238482PowerTrialysisBard Access Systems, Inc.NIE2026-04-13
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