Acute Single Lumen Catheter,Straight Extension,8 Fr/Ch (2.7 mm) x 19.5 cm
Argyle - 8817232019
Device Description
A sterile, flexible, single-lumen tube intended to be used for short-term (< 30 days) peripheral arteriovenous access during extracorporeal blood therapies (i.e., haemodialysis haemoperfusion and/or apheresis), to conduct blood from a patient and to return it after extracorporeal circulation. It is designed to withstand elevated pressures associated with arteriovenous access (i.e., via shunt or fistula), and may be intended for single-needle technique (i.e., sequential bidirectional flow) and/or double-needle technique (i.e., using two catheters). Devices dedicated to catheter introduction/function (e.g., introducer needle, stylet) may be included. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Length: 19.5 Centimeter
- Catheter Gauge: 8 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LFJ
Device Name: Catheter, Subclavian
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 876.5540
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 20884521070322
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521070325
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK
Device Id: 10884521070325
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