Duns Number:079375431
Device Description: CORFLO* Nasogastric/Nasointestinal Feeding Tube with Stylet with ENFit® Connector
Catalog Number
42-9431
Brand Name
CORFLO*
Version/Model Number
42-9431
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"
-
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
057094e3-1159-4c44-a5d2-0de42bd611e4
Public Version Date
April 29, 2021
Public Version Number
1
DI Record Publish Date
April 21, 2021
Package DI Number
10350770471690
Quantity per Package
10
Contains DI Package
00350770471693
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |