- Physicians Office Resource

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

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 Identifiers

Device 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

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