AccessGUDID - DEVICE: Tube Organiser (05051223004424)

GUDID

Device Identifier (DI) Information

Brand Name: Tube Organiser
Version or Model: PS5100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS5100
Company Name: PURPLE SURGICAL INTERNATIONAL LIMITED

Primary DI Number: 05051223004424
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 239403863 *Terms of Use

Device Description: The Tube Organiser is used to secure and organize tubing, cables & leads. The use of the Tube organiser helps ensure the surgical work area is kept free of the potential of trip and entanglement hazards associated with loose tubing during procedures, and aids prevention of kinking and possible occlusion.

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":	No
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?
56630	Universal patient tubing holder, sterile	A small, sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	Tubing, Pressure And Accessories

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
Device Size Text, specify: 110mm length x 15mm width

Device Record Status

Public Device Record Key: 57f7ce63-457c-4ab8-88e6-9901c6ae9dd9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016