Duns Number:038101861
Device Description: 10FR x 110cm NutraGlide Nasal Feeding Tube with Stylet and ENFit® (Sterile, Pouched)
Catalog Number
ESNFT-10110-I
Brand Name
NutraGlide Nasal Feeding Tube
Version/Model Number
ESNFT-10110-I
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K202539,K202539
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
8cf7e827-1b4b-451f-91c3-c8229a484b64
Public Version Date
March 09, 2021
Public Version Number
1
DI Record Publish Date
March 01, 2021
Package DI Number
00842071128029
Quantity per Package
10
Contains DI Package
00842071127381
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box (SNFT-10110-I)
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 26 |
2 | A medical device with a moderate to high risk that requires special controls. | 1325 |