Fluid Management System, Integrated Tube Set, Do not use if package is damaged, Keep dry, Keep away from sunlight, Keep away from heat and radioactive sources


Product Overview

Fluid Management System, Integrated Tube Set, Do not use if package is damaged, Keep dry, Keep away from sunlight, Keep away from heat and radioactive sources
Fluid Safe - 0502200000A


Device Description

A mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: HIG

Device Name: Insufflator, Hysteroscopic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

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: 884.1700

Third Party Flag: Y

Medical Specialty: OB


Device Identifiers

Device Id: 37613327055840

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613327055849

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack


Device Id: 07613327055849

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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