FDA.reportPublic FDA data

Signature Care Saline Wound Wash

Primary DI
00321130210009
Brand
Signature Care Saline Wound Wash
Company
BETTER LIVING BRANDS LLC
Model
21000
Device description
Sterile Saline Wound Wash. Packaged in an aerosol (BOV).
Published
2022-11-01
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
10321130210006PackageGS148In Commercial Distribution
00321130210009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1032113021000610321130210006
00321130210009003211302100093211302100090321130210009

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit120 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
080349866
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00021130794461Signature CareSAF4025RSAF4025R2026-07-16
00321130762843Signature Care3211307628432020-08-10
00321130762850Signature Care3211307628502020-08-10
00321130788812Signature Care3211307888122020-07-31
00321130144724Signature Care3211301447242020-07-31
00321130078210Signature Care3211300782102020-07-31
00321130211419Signature Select3211302114192025-10-02
00321130211426Signature Select3211302114262025-10-02
00021130163830Signature Care Digital Pregnancy Test2021-04-16
00321130352945Signature SelectOne Step Pregnancy TestN/A2025-02-27
00021130163823Signature Care One Step Pregnancy Test2021-04-16
00321130195900Signature Care321130195900X004JE7MZP2022-12-12
00321130351115AlbertsonsDigital Wide-Tip Pregnancy TestN/A2025-03-03
10321130351112AlbertsonsDigital Wide-Tip Pregnancy TestN/A2025-03-03
10321130352942Signature SelectOne Step Pregnancy TestN/A2025-02-27
00021130790005Signature Care Early Result Pregnancy Test2016-10-26
00321130195894Signature Care3211301958942022-12-12
10321130195891Signature Care3211301958942022-12-12
10321130195907Signature Care3211301959002022-12-12
00321130780595Safeway Facemask SAF384RSAF384R2016-09-24

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