Deluxe Fabric Leg Straps
Leg Bag - 150507
Device Description
A portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, headband, or clothing, or as a trolley with wheels. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NNW
Device Name: Bag, Urine Collection, Leg, For External Use, Non-Sterile
Device Class: 1
Physical State: N/A
Definition: Urine collector and accessories; see product code FAQ.
Submission Type ID: 4
Review Panel: GU
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 876.5250
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 10801741050814
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741050817
Package Quantity: 24
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 00801741050817
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