AccessGUDID - DEVICE: Biomedical Pharma® (08050999240019)

GUDID

Device Identifier (DI) Information

Brand Name: Biomedical Pharma®
Version or Model: 754595
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: POWER METAL ITALIA SRL

Primary DI Number: 08050999240019
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 436177248 *Terms of Use

Device Description: PhotoACTIVE® WASH is a Silver water-based general purpose laundry sanitizer suitable for fabrics and clothes. Antiviral and Antibacterial performance is activated by natural or artificial lights and remains at least for 30 washes. HOW TO USE: In order to acheive the complete Anti-Viral and Anti-Bacterial performances you have to add one scoop (50 ml for 6 kg of laundry) of PhotoACTIVE® WASH into your machine softener’s compartment. .

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
65345	Durable disinfectant coating	A substance (e.g., ready-to-use solution or solution additive) intended to be applied to a surface, noninvasive device, or clothing to create an enduring (long-life) coating with an antimicrobial and/or antiviral effect, that inactivates and destroys pathogens with a specific mechanism (e.g., photocatalytic oxidation, oligodynamic effect).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, Medical Devices

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: 895bf760-25e3-4f94-9fd5-24ab7cb0c3df
Public Version Date: February 01, 2024
Public Version Number: 3
DI Record Publish Date: May 31, 2021