Duns Number:079375431
Device Description: CORFLO* Nasogastric/Nasointestinal Feeding Tube with Stylet with ANTI-IV* Connector
Catalog Number
20-9438AIV2
Brand Name
AVANOS
Version/Model Number
20-9438AIV2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPD
Product Code Name
TUBE, FEEDING
Public Device Record Key
068f1161-93cc-4535-b1bb-fa3f58fe0348
Public Version Date
August 17, 2020
Public Version Number
1
DI Record Publish Date
August 07, 2020
Package DI Number
10350770458073
Quantity per Package
10
Contains DI Package
00350770458076
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 |