FDA.reportPublic FDA data

Family Wellness Saline Wound Wash

Primary DI
00032251985164
Brand
Family Wellness Saline Wound Wash
Company
Family Dollar Stores
Model
997345
Device description
Sterile Saline Wound Wash. Packaged in an aerosol (BOV).
Published
2024-03-10
Public version status
New
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
10032251985161PackageGS148In Commercial Distribution
00032251985164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003225198516110032251985161
00032251985164000322519851640322519851640032251985164

GMDN Terms#

Term, Definition table
TermDefinition
Non-antimicrobial wound irrigation solution, salineA solution of sodium chloride (NaCl), without additional compounds (i.e., not a multiple solute solution), 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 may be supplied in a plastic container with a spray nozzle; it is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
914-667-6200mrahman@premier-brands.com

Regulatory Flags#

DUNS number
117310689
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00032251578113Family Wellness099901086-9142020-01-27
00032251689659FAMILY WELLNESSSKU9037562025-08-01
00032251689666FAMILY WELLNESSSKU9395042025-08-01
00032251689888FAMILY WELLNESSSKU9976692025-08-01
20032251689653FAMILY WELLNESSSKU9397562025-08-01
10032251689663FAMILY WELLNESSSKU9395042025-08-01
10032251689885FAMILY WELLNESSSKU9976692025-08-01
00032251627620Family Wellness9160612020-08-07
00032251627910Family Wellness9995772020-07-09
00032251921612Family Wellness99957786-359FD2023-10-06
00032251921629Family Wellness91606186-3522023-10-06
00032251057489Family Wellness03225105748909088262020-02-28
00032251057502Family Wellness03225105750209088282020-02-28
00032251057847Family Wellness03225105784709032212020-02-28
00032251058158Family Wellness03225105815809108672020-02-28
00032251911798Family Wellness9028072024-07-08
00032251911804Family Wellness9028062024-07-08
00032251911842Family Wellness9398562024-07-08
00032251911859Family Wellness9996002024-07-08
00032251911866Family Wellness9999862024-07-08

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