FLOW UNIT 4

FLOW UNIT 4
N/A - EPSC004INT

A collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NZA

Device Name: Accessories, Germicide, Cleaning, For Endoscopes

Device Class: 2

Physical State: High level disinfection of reusable, heat-sensitive devices

Definition: High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: High level disinfection of reusable, heat-sensitive devices

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: High level disinfection of reusable, heat-sensitive devices

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04961333243051

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