FDA.report

MAHURKAR

Primary DI
20884521005232
Brand
MAHURKAR
Company
Covidien LP
Model
8831661001
Catalog number
8831661001
Device description
Acute Dual Lumen Catheter Kit,Straight Extensions,11.5 Fr/Ch (3.8 mm) x 24 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

Related Records

Contact Domains

Product Codes

CodeName
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521005232PackageGS15In Commercial Distribution
10884521005235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452100523220884521005232
1088452100523510884521005235

GMDN Terms

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

TypeValueUnit
Catheter Gauge11.5French
Length24Centimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00; Avoid direct sunlight
Special Storage Condition, Specify00Avoid direct sunlight

Sterilization Methods

Method

Contacts

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

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