RENASYS TOUCH Class I Power Supply

RENASYS TOUCH Class I Power Supply
RENASYS TOUCH Class I Power Supply - 66801285

A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. 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: OMP

Device Name: Negative Pressure Wound Therapy Powered Suction Pump

Device Class: 2

Physical State: Powered suction pump and wound dressing kit

Definition: For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The wound bed is dressed, fitted with mode of communication between the wound bed and suction apparatus, and sealed (according to labeling instructions). The suction apparatus is engaged to create a vacuum (negative pressure) within the wound bed drives the wound exudate to be pumped from the wound bed into a collection canister. The device is designed to provide a pre-set level of negative pressure to the wound bed.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: For management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Regulation Number: 878.4780

Third Party Flag: N

Medical Specialty: SU

Device Id: 05000223495527

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05000223495510

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 05000223495510

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