AccessGUDID - DEVICE: M-Drain Centesis Catheter (15711055001967)

GUDID

Device Identifier (DI) Information

Brand Name: M-Drain Centesis Catheter
Version or Model: D40104010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D40104010
Company Name: Mermaid Medical A/S

Primary DI Number: 15711055001967
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308951313 *Terms of Use

Device Description: M-Drain Centesis Catheter is used in percutaneous fluid aspirations and small volume drainage procedures.

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?
47796	Multi-purpose percutaneous abdominothoracic drainage catheter	A flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GCB	Needle, Catheter

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
Special Storage Condition, Specify: Keep away from sunlight and keep dry

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 4 French
Length: 10 Centimeter

Device Record Status

Public Device Record Key: 1513f726-d9fc-44bb-8e1f-445b220d60e5
Public Version Date: September 09, 2020
Public Version Number: 2
DI Record Publish Date: August 05, 2019