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

Other Devices From This Company#

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01714196637702HydraLock SA with Border637702026-07-16
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00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz Tube111052026-06-01
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01714196112452DermaRite Medical Wound Gel- Amorphous Hydrogel112452026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4222042026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4333042026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz Tube20301US2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz Tube20501US2026-06-01
00714196112453DermaSyn112452020-09-01
00714196930712Bordered Foam Healogics by DermaRite930712020-09-01
00714196930736Bordered Foam Healogics by DermaRite930732020-09-01
01714196422629ComfortGauze Border422622025-01-08
01714196422636ComfortGauze Border422632025-01-08
07141964645074AquaRite Ag Extra CMC464502025-06-01
07141964666000AquaRite Ag Extra CMC466602025-06-01
71419624712486DermaSyn002472024-10-21

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Primary DI, Brand, Company table
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00850022135347VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
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