AccessGUDID - DEVICE: Marina Medical (00840306822780)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 190-612
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 190-612
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306822780
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: Poole Aspiration Tube - 30fr with valve

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:	No
Prescription Use (Rx):	No
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?
46686	Endoscopic overtube, reusable	A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCZ	TUBE, SMOKE REMOVAL, ENDOSCOPIC

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 30 French

Device Record Status

Public Device Record Key: 8e666378-668d-4615-9383-1e28a83576a9
Public Version Date: January 17, 2025
Public Version Number: 2
DI Record Publish Date: April 18, 2024