Duns Number:016898496
Device Description: Bard® Premature Infant Feeding Tube
Catalog Number
0036430
Brand Name
Bard® Premature Infant Feeding Tube
Version/Model Number
0036430
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
FPD
Product Code Name
TUBE, FEEDING
Public Device Record Key
5f17d50c-5f4b-4d1d-ae99-4d6f5a8c549c
Public Version Date
June 30, 2022
Public Version Number
3
DI Record Publish Date
August 16, 2016
Package DI Number
10801741034432
Quantity per Package
50
Contains DI Package
00801741034435
Package Discontinue Date
March 31, 2020
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 | 472 |
2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
U | Unclassified | 10 |