AccessGUDID - DEVICE: Tru-Fix Catheter Fixation Kit (H862TFK080)

GUDID

Device Identifier (DI) Information

Brand Name: Tru-Fix Catheter Fixation Kit
Version or Model: TFK-08
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TFK-08
Company Name: URESIL, LLC

Primary DI Number: H862TFK080
Issuing Agency: HIBCC
Commercial Distribution End Date: June 30, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: Tru-Fix Catheter Fixation Kit - 8F

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56631	Wearable percutaneous catheter/tube holder	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 8 French

Device Record Status

Public Device Record Key: ce42a0ac-bd29-4306-a22f-6fae6ea338cc
Public Version Date: May 13, 2022
Public Version Number: 6
DI Record Publish Date: August 31, 2016