Duns Number:825673239
Device Description: AMSure® Enteral Irrigation Kit with Bulb SyringeClean, Ready to UseCONTENTS:• 1 Graduated AMSure® Enteral Irrigation Kit with Bulb SyringeClean, Ready to UseCONTENTS:• 1 Graduated Container, 500 ml• 1 Bulb Irrigation Syringe, 60 ml• 1 Small Tube Adapter• 1 Patient ID Label
Catalog Number
AS121
Brand Name
AMSure® Enteral Irrigation Kit with Bulb Syringe
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
40c107ef-01f3-4630-ae32-71b665fba237
Public Version Date
July 06, 2018
Public Version Number
1
DI Record Publish Date
June 05, 2018
Package DI Number
40704411008485
Quantity per Package
30
Contains DI Package
10704411008484
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 |