FDA.reportPublic FDA data

MAHURKAR

Primary DI
10884521057319
Brand
MAHURKAR
Company
Mozarc Medical US LLC
Model
8888135137
Device description
Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Components,13.5 Fr/Ch (4.5 mm) x 13.5 cm
Published
2015-08-31
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
MPBCATHETER, HEMODIALYSIS, NON-IMPLANTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPBCatheter, Hemodialysis, Non-ImplantedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521057319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452105731910884521057319

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, nonimplantableA flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein 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 and may be radiopaque; 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 Gauge13.5French
Length13.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00; Avoid direct sunlight
Special Storage Condition, Specify00Avoid direct sunlight
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

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
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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