- Physicians Office Resource

Water Pump for Model HPU-20 - MAJ-527

Device Description

An electrically-powered device, which may include noninvasive accessories, intended to pump a sterile fluid (e.g., saline water) to irrigate body cavities/wounds during surgery (e.g., general surgery, endoscopic). It is typically intended to be used to wash away tissues/fluids/debris with a sterile fluid to facilitate observation; it is not intended to administer parenteral fluids or drugs and is not capable of suction. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

High-level Disinfectant

Moist Heat or Steam Sterilization

High-level Disinfectant
Moist Heat or Steam Sterilization

Product Codes

Code: KNS

Device Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

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: 876.4300

Third Party Flag: Y

Medical Specialty: GU

Device Identifiers

Device Id: 04953170022791

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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