Duns Number:016898496
Device Description: Bard® Levin Tube
Catalog Number
0044140
Brand Name
Bard® Levin Tube
Version/Model Number
0044140
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
FRQ
Product Code Name
TUBE, LEVINE
Public Device Record Key
853d5662-2ea5-4313-a9f0-5aad63251b6e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 16, 2016
Package DI Number
10801741045780
Quantity per Package
50
Contains DI Package
00801741045783
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 |