Duns Number:025460908
Device Description: NG FEED TUBE, ENFIT, 8FR, 50CM, STYLET
Catalog Number
ENFIT08050S
Brand Name
Medline
Version/Model Number
ENFIT08050S
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
1a90e9c7-b39c-451d-976d-113a91b40279
Public Version Date
December 17, 2020
Public Version Number
1
DI Record Publish Date
December 09, 2020
Package DI Number
20888277725048
Quantity per Package
10
Contains DI Package
10888277725041
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 |