FDA.reportPublic FDA data

SafeWash Saline

Primary DI
00714196245076
Brand
SafeWash Saline
Company
Sion Brands LLC
Model
00245
Device description
SafeWash™ Saline is a sterile first-aid, multi-use jet lavage for wound dressing irrigation and wound cleansing. SafeWash™ Saline wound wash is intended for: moistening and lubricating absorbent wound dressings; cleansing wounds, scrapes and minor burns; flushing and cleansing wounds of exudate, loose necrotic tissue, and foreign material such as dirt and debris. Contains 0.9% Sodium Chloride Solution.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10714196245073PackageGS112In Commercial Distribution
00714196245076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071419624507310714196245073
00714196245076007141962450767141962450760714196245076

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

Regulatory Flags#

DUNS number
118753405
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00714196930736Bordered Foam Healogics by DermaRite930732020-09-01
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