SafeWash Saline

GUDID 00714196245076

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.

DERMARITE INDUSTRIES LLC

Wound irrigation sterile saline Wound irrigation sterile saline
Primary Device ID00714196245076
NIH Device Record Key972fd3bf-a11c-486e-9c55-5601dd4c2e0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafeWash Saline
Version Model Number00245
Company DUNS883925562
Company NameDERMARITE INDUSTRIES LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100714196245076 [Primary]
GS110714196245073 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

FQHLavage, Jet

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-20

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