AccessGUDID - DEVICE: Medegen Medical Products, LLC (00700812000082)

GUDID

Device Identifier (DI) Information

Brand Name: Medegen Medical Products, LLC
Version or Model: 00063
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDEGEN MEDICAL PRODUCTS, LLC

Primary DI Number: 00700812000082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 055527753 *Terms of Use

Device Description: Basin Emesis 700cc Blue 24/cs 336/plt

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):	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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 95ea6c1c-adea-4d67-acaa-6eb565c32c85
Public Version Date: December 28, 2020
Public Version Number: 1
DI Record Publish Date: December 20, 2020