AccessGUDID - DEVICE: Medegen Medical Products (00700812016427)

GUDID

Device Identifier (DI) Information

Brand Name: Medegen Medical Products
Version or Model: 541-5078-0000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 541-5078-0000
Company Name: MEDEGEN MEDICAL PRODUCTS, LLC

Primary DI Number: 00700812016427
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 055527753 *Terms of Use

Device Description: 7QT. Wash Basin Gold 50/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?
35588	Washbowl, reusable	A portable rigid container designed to be filled with water and carried to the point of use to wash a patient who typically needs assistance (e.g., a bed-bound, geriatric, and/or disabled patient). It may be designed to be placed in a dedicated bowl/basin stand. 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: 7ea3e8ec-b761-4d13-99a0-9e75cc75a2a7
Public Version Date: October 29, 2021
Public Version Number: 2
DI Record Publish Date: August 31, 2020