CAP,CONNECTOR FOR WATER JET,5 PIECES FOR

CAP,CONNECTOR FOR WATER JET,5 PIECES FOR
N/A - KUMOF-B118K

Device Description

A device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] and/or water whilst preventing backflow. It is in the form of an attachable valve with one or more settings such as closed, insufflation (allowing air/gas in), and irrigation/rinse (allowing water in). This is a reusable device intended to be reprocessed prior to use.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

Ethylene Oxide

Moist Heat or Steam Sterilization

High-level Disinfectant

Sound Waves

Ethylene Oxide
Moist Heat or Steam Sterilization
High-level Disinfectant
Sound Waves

Product Codes

Code: FDS

Device Name: Gastroscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with gastroscope

Definition: To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Inserted orally into the stomach

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: stomach

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 04961333243372

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