Duns Number:044611812
Device Description: Bolus Tube for 24 Fr
Catalog Number
000259
Brand Name
Bard Button Device Bolus Feeding Tube with Straight Adaptor
Version/Model Number
000259
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
-
Product Code
KGC
Product Code Name
TUBE, GASTRO-ENTEROSTOMY
Public Device Record Key
06da82d3-b545-4ea1-b170-38d5f5fa2ce3
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
10801741080859
Quantity per Package
17
Contains DI Package
00801741080852
Package Discontinue Date
August 31, 2014
Package Status
Not 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 |