Premier Solution Saline Wound Wash

GUDID 10034197018477

Sterile Saline Wound Wash. Packaged in an aerosol (BOV).

Premier Brands of America Inc.

Non-antimicrobial wound irrigation solution, saline
Primary Device ID10034197018477
NIH Device Record Key8a4caefd-c8f9-4133-905a-3ab244dc4693
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremier Solution Saline Wound Wash
Version Model Number1847
Company DUNS063849780
Company NamePremier Brands of America 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 Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com
Phone914-667-6200
Emailmrahman@premier-brands.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100034197018470 [Primary]
GS110034197018477 [Package]
Contains: 00034197018470
Package: Case [48 Units]
In Commercial Distribution

FDA Product Code

FQHLavage, Jet

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-20
Device Publish Date2024-03-12

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