AccessGUDID - DEVICE: Diversatek Healthcare (M7831240120)

GUDID

Device Identifier (DI) Information

Brand Name: Diversatek Healthcare
Version or Model: 1240-12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1240-12
Company Name: DIVERSATEK HEALTHCARE, INC.

Primary DI Number: M7831240120
Issuing Agency: HIBCC
Commercial Distribution End Date: June 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 030650113 *Terms of Use

Device Description: Straight Thoracic Catheter, 12 French x 20 IN

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?
37482	Pleural catheter	A tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after surgery or chest trauma. It is typically used with a pleural drainage system that uses a low negative pressure through the drain lumen. Often referred to as a chest tube, it is typically made of silicone and is available in various designs, shapes, and sizes; it may include disposable devices dedicated to catheter introduction, however it does not include fluid collection bags/containers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBS	Catheter, Ventricular, General & Plastic Surgery

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
Length: 20 Inch
Catheter Gauge: 12 French

Device Record Status

Public Device Record Key: 0b159069-6f1d-4fe8-bc95-733488e24d17
Public Version Date: January 03, 2024
Public Version Number: 7
DI Record Publish Date: December 23, 2016