Duns Number:825673239
Device Description: Enteral Administration Kit, 1200 mL Enteral Gravity Bag, Large bore tubing with Enfit® con Enteral Administration Kit, 1200 mL Enteral Gravity Bag, Large bore tubing with Enfit® connector and transition connector
Catalog Number
ENF1203KLD
Brand Name
Enteral Administration Kit, 1200 mL Bag with Enfit® connector
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
cb542ced-791c-4a5d-9fae-66f92f6fb12a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 15, 2018
Package DI Number
40704411007426
Quantity per Package
30
Contains DI Package
10704411007425
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 |