Duns Number:025460908
Device Description: DBD-ENFIT PISTON SYRINGE,FEED TRAY, 30/C
Catalog Number
ENFIT7061
Brand Name
Medline
Version/Model Number
ENFIT7061
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
K160642,K160642
Product Code
PIF
Product Code Name
Gastrointestinal Tubes with Enteral Specific Connectors
Public Device Record Key
b4f2c89f-516d-4770-889d-7d1701a82890
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
October 15, 2021
Package DI Number
20888277677712
Quantity per Package
30
Contains DI Package
10888277677715
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 |