Duns Number:053146767
Device Description: WT 125 Water Trap collects condensate from a ventilator circuit. A spring-loaded plunger
Catalog Number
WT 125
Brand Name
WT 125 Water Trap
Version/Model Number
WT 125
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
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
956e5575-f5f2-40e7-8a9d-24402b8f963a
Public Version Date
May 06, 2019
Public Version Number
1
DI Record Publish Date
April 26, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |