Duns Number:078851039
Device Description: Enteral Pump Bag Bag Set with ENFit
Catalog Number
-
Brand Name
Generica Medical
Version/Model Number
GMI-2000PBS
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
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
K133077,K133077
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
0c50d484-1072-471b-9a7c-c58a6721302d
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
20859261004036
Quantity per Package
30
Contains DI Package
00859261004087
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |