Duns Number:600111512
Device Description: Watertrap
Catalog Number
-
Brand Name
Microstream Luer
Version/Model Number
010993
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2022
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
BYH
Product Code Name
DRAIN, TEE (WATER TRAP)
Public Device Record Key
48690748-ca8e-47b1-9b16-50e87eff7150
Public Version Date
August 22, 2022
Public Version Number
5
DI Record Publish Date
May 04, 2019
Package DI Number
10884521762176
Quantity per Package
10
Contains DI Package
20884521520735
Package Discontinue Date
March 31, 2022
Package Status
Not in Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 154 |