Closed Male Luer

Closed Male Luer
Alaris, Texium - 10012241-0500

A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: ONB

Device Name: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Device Class: 2

Physical State: Vial adator with piercing spikes, contain Luer-Lock connector fitted with elastomeric membrane to provide a sealed connection between syringe, I.V. administration set or tranfer bag. May contain side pressure-equalizing protector unit. May contain needle-free access port.

Definition: Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Placed over vial or container containing the chemotheraphy drug

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Device is not act on any part of body. I.V. infusion devices, catheters, drug container closure system.

Regulation Number: 880.5440

Third Party Flag: N

Medical Specialty: HO

Device Id: 10885403221705

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: 20885403221702

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403221705

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 50885403221703

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20885403221702

Package Quantity: 100

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case