AccessGUDID - DEVICE: Medegen Medical Products, LLC (00700812001256)

GUDID

Device Identifier (DI) Information

Brand Name: Medegen Medical Products, LLC
Version or Model: H145-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDEGEN MEDICAL PRODUCTS, LLC

Primary DI Number: 00700812001256
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 36
Labeler D-U-N-S® Number*: 055527753 *Terms of Use

Device Description: Urinal Female Transl 36/cs 16/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?
37977	Hand-held urinal, female	A portable, hand-held container/set, typically made of plastic, intended to be directly urinated into by a female (typically bed-bound) patient for excretory purposes. The opening for urination will typically be elongated and have slightly raised edges that fit to the female genital anatomy. The device may have a drain with a stopper in it to facilitate emptying; it is not intended to be worn by the patient. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FNP	URINAL

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: 30410368-43ea-4a3d-b763-e8c10f8dd7ad
Public Version Date: December 28, 2020
Public Version Number: 1
DI Record Publish Date: December 20, 2020