All-Channnel Irrigator

All-Channnel Irrigator - CW-4

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: True

Sterilization Methods:

• High-level Disinfectant
• Ethylene Oxide

Code: ODG

Device Name: Endoscopic Ultrasound System, Gastroenterology-Urology

Device Class: 2

Physical State: ultrasound system and system accessories, endoscope

Definition: To provide ultrasonic visualization of body cavities that can be accessed by endoscope. 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: Uses ultrasound to visualize body cavities through endoscope

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various body cavities, hollow organs, and canals in GI and GU tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: FDT

Device Name: Duodenoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with duodenoscope

Definition: To examine the duodenum and to perform various procedures within the duodenum. 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: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Inserted orally into duodenum

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: duodenum, esophagus

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

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

Code: FDF

Device Name: Colonoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with colonoscope

Definition: To examine or perform procedures in the colon or rectum 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 into anus

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: colon or rectum

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170355707

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