Duns Number:044611812
Device Description: 9 Fr Guidewire J-Tube
Catalog Number
000732
Brand Name
Bard Wire-Guided Jejunal Feeding/Gastric Decompression Tube
Version/Model Number
000732
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
d0438ca3-9494-41f2-8dcd-e840655eb98b
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
20801741051665
Quantity per Package
15
Contains DI Package
10801741051668
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
U | Unclassified | 8 |