Duns Number:025460908
Device Description: SET,GVTY FEEDING BG 1000ML,ENFIT,ALT
Catalog Number
ENFIT70503A
Brand Name
Medline
Version/Model Number
ENFIT70503A
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
9256d060-19cc-4fdf-ae28-ac67ccf5d937
Public Version Date
November 11, 2021
Public Version Number
1
DI Record Publish Date
November 03, 2021
Package DI Number
20193489033219
Quantity per Package
30
Contains DI Package
10193489033212
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |