StatLock 2
Catheter Stabilization Device - FOL0102
Device Description
A device designed to be attached to a patient's body to hold an indwelling urinary catheter line (e.g., Foley) in place. It consists of a wrap or adhesive strip/pad placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip) without creating excessive pressure on it and permitting visual inspection of the site. It is not designed to hold a urine collection bag. This is a single-use device.
Environmental Conditions
- Keep away from sunlight
- Keep dry
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: EYJ
Device Name: Holder, Ureteral Catheter
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 876.5130
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 20801741076118
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10801741076111
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 10801741076111
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741076114
Package Quantity: 25
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 00801741076114
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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