FDA.report

LMI IRRIGATION (STRAIGHT) CATHETER

Primary DI
B3805FIGR800
Brand
LMI IRRIGATION (STRAIGHT) CATHETER
Company
LUCAS MEDICAL INC
Model
5FIGR80
Published
2016-09-02
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

Product Codes

CodeName
DXECatheter, Embolectomy

Product Code Classifications

CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B3805FIGR800PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical irrigation/aspiration systemAn assembly of devices used to intermittently or continuously irrigate and/or aspirate body cavities and wounds during a general surgical procedure. It provides for the removal of loose tissue, fluids, and other debris to keep the surgical site clear, helping to optimize visualization and access. The assembly typically includes a mains electricity (AC-powered) pump, collection bottles, tubing, and connectors. It may be used together with an irrigation catheter. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
878198993
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B3804FBBIR440D0LMI BILUMEN BILIARY CATHETER DISTAL4FBBIR440D2019-07-15
B3805FBBIR540D0LMI BILUMEN BILIARY CATHETER DISTAL5FBBIR540D2019-07-15
B3806FBBIR640D0LMI BILUMEN BILIARY CATHETER DISTAL6FBBIR640D2019-07-15
B3807FBBIR740D0LMI BILUMEN BILIARY CATHETER DISTAL7FBBIR740D2019-07-15
B3803FOCC230LMI OCCLUSION CATHETER3FOCC232016-09-02
B3803FOCC400LMI OCCLUSION CATHETER3FOCC402016-09-02
B3804FIRR040D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTO4FIRR040D2016-09-06
B3804FIRR040P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLEC4FIRR040P2016-09-06
B3804FIRR080D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTO4FIRR080D2016-09-06
B3804FIRR080P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLEC4FIRR080P2016-09-06
B3804FOCC230LMI OCCLUSION CATHETER4FOCC232016-09-02
B3804FOCC400LMI OCCLUSION CATHETER4FOCC402016-09-02
B3805FIRR040D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTO5FIRR040D2016-09-06
B3805FIRR040P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLEC5FIRR040P2016-09-06
B3805FIRR080D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTO5FIRR080D2016-09-06
B3805FIRR080P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLEC5FIRR080P2016-09-06
B3805FOCC230LMI OCCLUSION CATHETER5FOCC232016-09-02
B3805FOCC400LMI OCCLUSION CATHETER5FOCC402016-09-02
B3806FIRR040D0LMI BILUMEN IRRIGATION (DISTAL) ARTERIAL EMBOLECTO6FIRR040D2016-09-06
B3806FIRR040P0LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLEC6FIRR040P2016-09-06

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