FDA.reportPublic FDA data

MAHURKAR

Primary DI
10884521519534
Brand
MAHURKAR
Company
Covidien LP
Model
8888135140
Catalog number
8888135140
Device description
Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC Components
Published
2017-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030209000MAHURKAR OPLUS CATHETER, MODEL 13.5 FRThe Kendall Company2003-05-13MPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521519534PackageGS115In Commercial Distribution
20884521058382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452151953410884521519534
2088452105838220884521058382

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, nonimplantableA sterile, 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
Length16Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00;
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com
+39053529111RegulatoryOperations@mozarcmedical.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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