TRU-SECURE IV CATHETER SECUREMENT

TRU
Tru-Secure - TS1000

A device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FPA

Device Name: Set, Administration, Intravascular

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

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: 880.5440

Third Party Flag: Y

Medical Specialty: HO

Device Id: 20885403237895

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403237898

Package Quantity: 1200

Package Discontinue Date: 2/1/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 10885403237898

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: 50885403237896

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403237898

Package Quantity: 100

Package Discontinue Date: 2/1/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Shelfpack