FDA.reportPublic FDA data

CVS Sterile Saline Wound Wash

Primary DI
00050428253519
Brand
CVS Sterile Saline Wound Wash
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
444795
Device description
Sterile Saline Wound Wash. Packaged in an BOV Aersol 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
Single use
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
10050428253516PackageGS112In Commercial Distribution
00050428253519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042825351610050428253516
00050428253519000504282535190504282535190050428253519

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 Temperature32 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
062312574
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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