PhaseOne Antimicrobial Solution 15050

GUDID 00860009268616

Sonoma Pharmaceuticals, Inc.

Non-antimicrobial wound irrigation solution, multiple solute
Primary Device ID00860009268616
NIH Device Record Keyb735fe8c-afb8-4a95-b5e4-af066ed69bca
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhaseOne Antimicrobial Solution
Version Model Number15050
Catalog Number15050
Company DUNS081642964
Company NameSonoma Pharmaceuticals, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce
Total Volume1.69 Fluid Ounce

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009268616 [Primary]
GS110860009268613 [Package]
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-18
Device Publish Date2025-07-10

On-Brand Devices [PhaseOne Antimicrobial Solution]

0086000926861615050
1086000926860615235
1085001549183915473

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.