Acute Dual Lumen Catheter Tray,Curved Extensions with IC* Components
MAHURKAR - 8815668011
Device Description
A 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.
Environmental Conditions
- 86.00
- 58.00
Device Sizes
- Length: 19.5 Centimeter
- Catheter Gauge: 11.5 French
- Length, 19.5, CM; French Catheter, 11.5, Guage;
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FOZ
Device Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.5200
Third Party Flag: Y
Medical Specialty: HO
Device IdentifiersDevice Id: 20884521004969
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521004962
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK
Device Id: 10884521004962
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 10884521519275
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20884521004969
Package Quantity: 4
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE