Duns Number:053146767
Device Description: SC 603-A allows the user to switch from regular O2 to humidified O2 easily. Has standard SC 603-A allows the user to switch from regular O2 to humidified O2 easily. Has standard male DISS fitting.
Catalog Number
SC 603A
Brand Name
SC 603A O2 Flow Selector Valve
Version/Model Number
SC 603-A
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
753e03c3-5074-4a0c-b745-0ba1fe0b8fa5
Public Version Date
November 04, 2019
Public Version Number
3
DI Record Publish Date
May 15, 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 |