PureWick Urine Collection System Kit, Non
PureWick Urine Collection System - PW100
Device Description
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.
Environmental Conditions
- 106.00
- 50.00
- 90.00
- 5.00
- 158.00
- -13.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 00801741185342
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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