Duns Number:938289980
Device Description: A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.
Catalog Number
201011-000
Brand Name
STOPCOCK, TMP 3-WAY W/LUER LOCK
Version/Model Number
201011-000
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"
-
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
DTZ
Product Code Name
Oxygenator, Cardiopulmonary Bypass
Public Device Record Key
b63f037d-5fe4-472c-af87-53b8222c97d4
Public Version Date
March 10, 2022
Public Version Number
3
DI Record Publish Date
September 14, 2015
Package DI Number
B0662010110007
Quantity per Package
75
Contains DI Package
B0662010110000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PARTIAL CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |