- Physicians Office Resource

HEARTRAIL III Guiding Catheter
HEARTRAIL - 40-5341

Device Description

A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.

Device Sizes

Lumen/Inner Diameter: 1.47 Millimeter

Length: 100 Centimeter

Pressure: 4826 KiloPascal

Shape name of distal shaft is JL4.0

Outer Diameter: 1.75 Millimeter

Lumen/Inner Diameter: 1.47 Millimeter
Length: 100 Centimeter
Pressure: 4826 KiloPascal
Shape name of distal shaft is JL4.0
Outer Diameter: 1.75 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DQO

Device Name: Catheter, Intravascular, Diagnostic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

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: 870.1200

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 54987350715284

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350715289

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 04987350715289

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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