Duns Number:002397347
Device Description: SMBORE EXT SET W/ H.F. STOPCOCKS, 34 IN.
Catalog Number
490127
Brand Name
Extension Set
Version/Model Number
490127
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
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
FMG
Product Code Name
Stopcock, i.V. Set
Public Device Record Key
853e2807-ee56-48f6-a9c7-1a745f0eb6cb
Public Version Date
May 12, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2016
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |