Duns Number:016898496
Device Description: Bard® Rectal Tube
Catalog Number
0006510
Brand Name
Bard® Rectal Tube
Version/Model Number
0006510
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
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
768bad6e-c2ee-4d1f-bfc1-ace83561afcd
Public Version Date
August 09, 2018
Public Version Number
3
DI Record Publish Date
August 16, 2016
Package DI Number
10801741045971
Quantity per Package
50
Contains DI Package
00801741045974
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 | 472 |
2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
U | Unclassified | 10 |