Duns Number:825673239
Device Description: AMSure® Sterile Normal Saline for Wound Flush devices are wound and device cleaning soluti AMSure® Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and fordevice irrigation. Sterile normal saline for wound flush are intended to be used in home care and should only be used by clinicians familiar with the treatment of possiblecomplications.
Catalog Number
AS398-1
Brand Name
AMSure®Sterile Normal Saline for Wound Flush
Version/Model Number
1
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181423,K181423
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
b99e8ae0-2370-4c5d-92bf-2edec9da232f
Public Version Date
December 02, 2019
Public Version Number
2
DI Record Publish Date
February 18, 2019
Package DI Number
40704411010358
Quantity per Package
48
Contains DI Package
00704411010350
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |