Duns Number:825673239
Device Description: AMSure® ENTERAL FEEDING BAG with ATTACHED PUMP MAGNET SET1200 mL Capacity, Sterile, Clean, AMSure® ENTERAL FEEDING BAG with ATTACHED PUMP MAGNET SET1200 mL Capacity, Sterile, Clean, ready to use
Catalog Number
ES-1200M
Brand Name
AMSure® ENTERAL FEEDING BAG with ATTACHED PUMP MAGNET SET
Version/Model Number
2
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
7b7161c3-57fc-42d1-b6c6-6c2a3df253f3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 03, 2017
Package DI Number
40704411006528
Quantity per Package
30
Contains DI Package
10704411006527
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 |