DryDoc Vacuum Station for Use with PureWick Female External Catheter

DryDoc Vacuum Station for Use with PureWick Female External Catheter
DryDoc Vacuum Station - DD15

An assembly of devices intended to be fitted to a home bed and used by an incontinent/bed-bound patient for the removal of excrement and subsequent washing during bed occupancy. It includes a mains electricity (AC-powered) air/water pumping unit with heated water reservoir; waste container; and controls connected via relevant tubing to a suction cup, which conforms to the patient’s perineum. It may also include a bed washing/suction hose for general body cleaning, and a shaped mattress to accommodate the system tubing. Waste (i.e., faeces, urine, and waste water) is intended to be removed through suction; a supply of water and air is used to clean and dry the patient after waste removal.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NZU

Device Name: Collector, Urine, Powered, Non Indwelling Catheter

Device Class: 1

Physical State: The device consists of a female designed cup, male cup, collection tubing, urine bag, pump, rechargeable batter, circuitry to control the operaton of the pump, software, and carrying case to be attached to a wheel chair or beside.

Definition: For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: Urine is collected in a collection cup and with the assistance of a battery powered pump the urine is drawn through tubing into a urine bag for storage.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The collection cup is place under the external meatus of the urethra

Regulation Number: 876.5250

Third Party Flag: N

Medical Specialty: GU

Device Id: 00801741151781

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: 10801741151788

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741151781

Package Quantity: 1

Package Discontinue Date: 8/31/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Other