FDA.reportPublic FDA data

Fred's Pharmacy

Primary DI
00084579118625
Brand
Fred's Pharmacy
Company
FRED'S, INC.
Model
11862
Device description
Sterile Saline Wound Wash. Packaged in an Aerosol (BOV) can.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10084579118622PackageGS148In Commercial Distribution
00084579118625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1008457911862210084579118622
00084579118625000845791186250845791186250084579118625

GMDN Terms#

Term, Definition table
TermDefinition
Wound irrigation sterile salineA sterile solution of sodium chloride (NaCl), sometimes with additional compounds, intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and is typically provided in an appropriate container. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature33 Degrees Fahrenheit120 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
718-690-7099riyirhiaro@premier-brands.com
(718)878-3097amathew@premier-brands.com

Regulatory Flags#

DUNS number
005866116
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00084579122424FRED'S TAMPONS FR12006F/22016-09-13
00084579122431FRED'S TAMPONS FR22006F/22016-09-13
00084579122455FRED'S TAMPONS FR11806UO2016-09-13
00084579122462FRED'S TAMPONS FR21806UO/22016-09-13
00084579122479FRED'S TAMPONS FR11806SO2016-09-13
00084579122486FRED'S TAMPONS FR21806S0/22016-09-13
00084579123032FRED'S TAMPONS FR32006F/22016-09-13
10084579122421FRED'S TAMPONS FR12006F/22016-09-13
10084579122438FRED'S TAMPONS FR22006F/22016-09-13
10084579122452FRED'S TAMPONS FR11806UO2016-09-13
10084579122469FRED'S TAMPONS FR21806UO/22016-09-13
10084579122476FRED'S TAMPONS FR11806SO2016-09-13
10084579122483FRED'S TAMPONS FR21806S0/22016-09-13
10084579123039FRED'S TAMPONS FR32006F/22016-09-13
00761059407577Fred's Unifine Pentips Plus - Micro 4mmx32GAN 3840FRDAN 3840FRD2016-09-19
00084579128570FRED'S SUPER DOLLAR2684962016-09-30
00084579128587FRED'S SUPER DOLLAR6371492016-09-30
00761059307570Fred's Unifine Pentips Plus - Short 8mmx31GAN 3830FRDAN 3830FRD2016-09-19
00761059842576Fred's Unifine Pentips Plus - Micro 4mmx32GAN 3840FRDAN 3840FRD2016-09-19
00761059507574Fred's Unifine Pentips Plus - Mini 5mmx31GAN 3850FRDAN 3850FRD2016-09-19

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