PureWick Female External Catheter, Not Made with Natural Rubber Latex

PureWick Female External Catheter, Not Made with Natural Rubber Latex
PureWick Female External Catheter - PWFX30

A non-sterile, urine drainage device designed for women that typically consists of a moulded collection cup, which may be partially inserted into the vagina, and a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

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: 20801741189054

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10801741189057

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BX

Device Id: 10801741189057

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741189050

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741189050

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