Duns Number:883925562
Device Description: SafeWash™ Saline is a sterile first-aid, multi-use jet lavage for wound dressing irrigatio 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.
Catalog Number
-
Brand Name
SafeWash Saline
Version/Model Number
00245
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQH
Product Code Name
Lavage, Jet
Public Device Record Key
972fd3bf-a11c-486e-9c55-5601dd4c2e0e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
Package DI Number
10714196245073
Quantity per Package
12
Contains DI Package
00714196245076
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 137 |
| U | Unclassified | 36 |