FDA.reportPublic FDA data

Simply Saline™ Sterile Saline Solution Wound Wash

Primary DI
00022600085539
Brand
Simply Saline™ Sterile Saline Solution Wound Wash
Company
CHURCH & DWIGHT CO., INC.
Model
00022600085539
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083355000WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553Blairex Laboratories, Inc.2008-12-29FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00022600085539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00022600085539000226000855390226000855390022600085539

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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)833-9532Consumer.Relations@churchdwight.com

Regulatory Flags#

DUNS number
001211952
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

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