Duns Number:081334483
Catalog Number
-
Brand Name
G.E.B. tubing
Version/Model Number
A
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYY
Product Code Name
Tube, Aspirating, Flexible, Connecting
Public Device Record Key
94c50a53-3e7a-4f95-bd41-a90fa118368f
Public Version Date
June 08, 2021
Public Version Number
5
DI Record Publish Date
September 21, 2018
Package DI Number
50860000082803
Quantity per Package
50
Contains DI Package
00860000082808
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |