Duns Number:025460908
Device Description: NG FEED TUBE, ENFIT, 8FR, 50CM, NO STYL
Catalog Number
ENFIT08050
Brand Name
Medline
Version/Model Number
ENFIT08050
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
PIF
Product Code Name
Gastrointestinal Tubes with Enteral Specific Connectors
Public Device Record Key
fd10bace-487e-460a-a500-dd463bd5d0b9
Public Version Date
October 18, 2021
Public Version Number
1
DI Record Publish Date
October 08, 2021
Package DI Number
20193489081029
Quantity per Package
10
Contains DI Package
10193489081022
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 |