Duns Number:656854379
Catalog Number
Durable Water Trap 15M
Brand Name
N/A
Version/Model Number
70105
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
-
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
BYH
Product Code Name
Drain, Tee (Water Trap)
Public Device Record Key
278f8090-191f-45a4-ad5b-61b9cb90b38c
Public Version Date
August 23, 2018
Public Version Number
3
DI Record Publish Date
October 15, 2015
Package DI Number
44710810085336
Quantity per Package
50
Contains DI Package
04710810085338
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |