AccessGUDID - DEVICE: Marina Medical (00840306805929)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 020-060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 020-060
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306805929
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: Emesis Basin, 15 x 9 x 4.5 cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
11522	Emesis bowl, reusable	A device designed as a receptacle for vomit or oral secretions, typically from an immobile patient (e.g., one confined to bed, chair, or wheelchair). It is typically shallow and kidney-shaped, and therefore commonly known as a kidney bowl or basin. It is typically made of high-grade stainless steel or durable plastic materials, and is also commonly used to hold and transport medical/surgical materials or instruments for a procedure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNY	BASIN, EMESIS

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
Device Size Text, specify: Length, 4.5 cm

Device Record Status

Public Device Record Key: e11f2264-fd70-4e5c-b414-9140b3a3068e
Public Version Date: February 07, 2024
Public Version Number: 1
DI Record Publish Date: January 30, 2024