Pediacyn All Natural Skin Care & First Aid 86018

GUDID 20850015491683

Sonoma Pharmaceuticals, Inc.

Non-antimicrobial wound irrigation solution, multiple solute
Primary Device ID20850015491683
NIH Device Record Key0bfd7d29-d171-4ac5-b85b-3ced0a881f31
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediacyn All Natural Skin Care & First Aid
Version Model Number86018
Catalog Number86018
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter

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
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
GS100850015491689 [Primary]
GS120850015491683 [Package]
Contains: 00850015491689
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 Date2023-05-15
Device Publish Date2023-05-05

Devices Manufactured by Sonoma Pharmaceuticals, Inc.

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20850034960009 - Dr. Burd's Wonder Spray2023-09-15
20850034960016 - Dr. Burd's Wonder Spray2023-09-15
20850015491621 - Rejuvacyn Plus Antipruritic Spray Gel2023-05-15
20850015491638 - Rejuvacyn Plus Dermal Spray2023-05-15
20850015491645 - Rejuvacyn Plus Dermal Spray2023-05-15

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