AccessGUDID - DEVICE: Malem (05060049630144)

GUDID

Device Identifier (DI) Information

Brand Name: Malem
Version or Model: PC9S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MALEM MEDICAL LIMITED

Primary DI Number: 05060049630144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 291490076 *Terms of Use

Device Description: Queen's Square Bladder Stimulator - Selectable (PC9S)

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":	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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Bladder-emptying vibratory stimulator	A battery-powered, hand-held device intended to be used in the home or healthcare facility by a patient to help initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation. It is an electronic unit with a handle and massaging head held against the skin surface that is typically used by patients who have problems voiding due to disorders of neuromuscular origin (e.g., multiple sclerosis).

GMDN Preferred Term Name

GMDN Definition

Bladder-emptying vibratory stimulator

A battery-powered, hand-held device intended to be used in the home or healthcare facility by a patient to help initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation. It is an electronic unit with a handle and massaging head held against the skin surface that is typically used by patients who have problems voiding due to disorders of neuromuscular origin (e.g., multiple sclerosis).

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

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: a426e6ac-56d5-46da-b4b8-7c1f576f45d7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 06, 2016