FDA.reportPublic FDA data

MAHURKAR

Primary DI
10884521057388
Brand
MAHURKAR
Company
Covidien LP
Model
8888135248
Catalog number
8888135248
Device description
Acute Dual Lumen Catheter Tray,High Flow Curved Extensions with IC* Components,13.5 Fr/Ch (4.5 mm) x 24 cm
Published
2015-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10884521057388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452105738810884521057388

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
Length24Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00; Avoid 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
058614483
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521091986NellcorSC-A-I2026-05-25
20884521841724Shiley50FXLTCP2026-03-17
20884521841687Shiley50FXLTCD2026-03-16
20884521841694Shiley60FXLTCD2026-03-16
20884521841700Shiley70FXLTCD2026-03-16
20884521841717Shiley80FXLTCD2026-03-16
20884521841731Shiley60FXLTCP2026-03-16
20884521841748Shiley70FXLTCP2026-03-16
20884521841755Shiley80FXLTCP2026-03-16
20884521841762Shiley50FXLTUD2026-03-16
20884521841779Shiley60FXLTUD2026-03-16
20884521841786Shiley70FXLTUD2026-03-16
20884521841793Shiley80FXLTUD2026-03-16
20884521841809Shiley50FXLTUP2026-03-16
20884521841816Shiley60FXLTUP2026-03-16
20884521841823Shiley70FXLTUP2026-03-16
20884521841830Shiley80FXLTUP2026-03-16
30884521841844Shiley50FXLTIN2026-03-16
20884521841854Shiley60FXLTIN2026-03-16
20884521841861Shiley70FXLTIN2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20801902225515ARROWTELEFLEX INCORPORATEDMPB2026-03-11
20801902222255ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222262ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222279ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222293ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222309ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222316ARROWTELEFLEX INCORPORATEDMPB2025-06-12
20801902222248ARROWTELEFLEX INCORPORATEDMPB2025-06-10
20801902221920ARROWTELEFLEX INCORPORATEDMPB2025-05-13
50884908182892DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182908DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182915DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182922DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182939DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182946DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182953DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182977DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182984DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182991DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183004DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183011DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183028DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183035DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183042DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183059DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183066DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183073DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183080DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908183097DUO-FLOW®Medical Components, Inc.MPB2025-05-09
50884908182960DUO-FLOW®Medical Components, Inc.MPB2025-05-06