Microcyn Skin & Wound Care 84491

GUDID 20189116000693

Sonoma Pharmaceuticals, Inc.

Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute

Primary Device ID	20189116000693
NIH Device Record Key	f01a47a0-0723-4a9c-994a-e5140f8f8daf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Microcyn Skin & Wound Care
Version Model Number	84491
Catalog Number	84491
Company DUNS	081642964
Company Name	Sonoma Pharmaceuticals, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter

Operating and Storage Conditions

Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00189116000699 [Primary]
GS1	20189116000693 [Package] Contains: 00189116000699 Package: Box [12 Units] In Commercial Distribution

FDA Product Code

FRO	Dressing, Wound, Drug

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-12-09
Device Publish Date	2022-12-01

On-Brand Devices [Microcyn Skin & Wound Care ]

20860439002099	84871
20189116000693	84491
20189116000501	84507