FDA.report

CVS Health

Primary DI
20050428330023
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
445417
Device description
Advanced Wound Wash, 8 FL OZ (237 mL)
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20050428330023PackageGS112In Commercial Distribution
00050428330029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2005042833002320050428330023
00050428330029000504283300290504283300290050428330029

GMDN Terms

TermDefinition
Non-antimicrobial wound irrigation solution, multiple soluteA solution of electrolytes sometimes with other compounds [not limited to sodium chloride (NaCl), therefore not a saline solution], intended to be used to irrigate and clean a superficial skin wound to support natural healing; it is not intended to provide antimicrobial activity. The device may be supplied in a plastic container with a spray nozzle and is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-746-7287xx@xx.xx

Regulatory Flags

DUNS number
062312574
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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