AccessGUDID - DEVICE: BE SMART GET PREPARED (00020424210618)

GUDID

Device Identifier (DI) Information

Brand Name: BE SMART GET PREPARED
Version or Model: 04HBC21061BOX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 657189531
Company Name: TOTAL RESOURCES INTERNATIONAL INC.

Primary DI Number: 00020424210618
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790160535 *Terms of Use

Device Description: SILVEX ® Antibacterial Nano Silver Wound Wash by Be Smart Get Prepared, 4 oz – Treats Minor Cuts, Abrasions, Lacerations, Sunburns, 1st & 2nd Degree Burns, Skin Irritations, Diabetic Ulcers, Pressure Ulcers, & Post-Surgical Wounds - (1) SILVEX® Silver Wound Wash [4 oz]

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):	Yes
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?
59523	Antimicrobial wound irrigation solution	A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151185	000

Device Exempt from Premarket Submission: No 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
Weight: 113.398093 Gram

Device Record Status

Public Device Record Key: 1f7fee33-a1b9-46ee-a8df-e9786ee79cf3
Public Version Date: January 16, 2024
Public Version Number: 1
DI Record Publish Date: January 08, 2024