Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,12 Fr/Ch (4.0 mm)
Argyle - 8815544002
Device Description
A collection of devices which includes an implantable device(s) intended to provide percutaneous, peripheral, arterial access to enable repeated introduction of a catheter (not included) into the vascular system over an extended period (e.g., months) without vascular wound closure. It includes an implantable non-steerable introducer sheath, an inner obturator/occluder, and typically an additional access device(s) [e.g., haemostatic valve, stylet]. The introducer sheath is typically anastomosed to the blood vessel and externalised via a subcutaneous tunnel; the occluder is intended to plug the introducer sheath between uses. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Catheter Gauge: 12 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FKO
Device Name: Catheter, Peritoneal Dialysis, Single Use
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: Y
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 876.5630
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 20884521024295
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521024298
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK
Device Id: 10884521024298
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