PICO 10X20CM DRESSING

PICO 10X20CM DRESSING
PICO - 66022022

A portable assembly of devices designed to apply suction to help heal traumatic and chronic skin wounds (e.g., grafts, incisions, burns, ulcers) with low to moderate levels of exudate. It typically consists of an electrically-powered vacuum pump, a highly-absorbent wound dressing and/or collection canister to contain the exudate, and a connection tube. The pump applies continuous or intermittent negative pressure to the wound via the tube/dressing to decompress capillaries/lymphatic vessels, improve blood/interstitial fluid circulation, draw wound edges together, facilitate granulation tissue formation, and prepare the wound bed for closure. This is a single-use device.

No Data Available

• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 7.9000 Inch
• Width: 3.8999 Inch

Device Sterile: True

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

Code: QFC

Device Name: Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

Device Class: 2

Physical State: The device is a portable suction pump that may or may not include a canister for fluid collection.

Definition: A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device, when used with legally marketed compatible dressings, applies negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The device, when used with legally marketed compatible dressings, is intended to be applied to closed surgical incisions after surgery.

Regulation Number: 878.4783

Third Party Flag: N

Medical Specialty: SU

Device Id: 05000223492076

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05000223494643

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CAR

Device Id: 05000223494643

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

Device Id: 05000223493462

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05000223492076

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CAS