AccessGUDID - DEVICE: Medegen Medical Products (00700812000464)

GUDID

Device Identifier (DI) Information

Brand Name: Medegen Medical Products
Version or Model: 02433
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02433
Company Name: MEDEGEN MEDICAL PRODUCTS, LLC

Primary DI Number: 00700812000464
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 055527753 *Terms of Use

Device Description: Bowl 32oz White Non-Sterile 250/cs 24/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?
42891	General-purpose bowl, single-use	A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This disposable device will typically be incinerated along with its contents if used for waste. This is a single-use 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: 0f3d6d58-88b3-4bfb-9a35-ce3db9c8a193
Public Version Date: October 29, 2021
Public Version Number: 2
DI Record Publish Date: August 31, 2020