FDA.reportPublic FDA data

MAHURKAR

Primary DI
20884521005140
Brand
MAHURKAR
Company
Covidien LP
Model
8830414002
Catalog number
8830414002
Device description
Acute Dual Lumen Catheter,Curved Extensions with 2 Sealing Caps,11.5 Fr/Ch (3.8 mm) x 16 cm
Published
2015-10-22
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
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521005140PackageGS15In Commercial Distribution
10884521005143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100514020884521005140
1088452100514310884521005143

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 Gauge11.5French
Length16Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00; Avoid direct sunlight

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
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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

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

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Primary DI, Brand, Company table
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30197344181517MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20197344181527MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20197344199690MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20801902225478ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225485ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225492ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
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30801902219375ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219392ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219422ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219439ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219446ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219453ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219477ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219491ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
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20801902219521ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219538ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219545ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219569ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219576ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219583ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219590ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
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