Duns Number:017246562
Device Description: EXT SET 63 IN
Catalog Number
MC330667
Brand Name
Centurion
Version/Model Number
MC330667
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
d0d43591-babc-446f-ae0f-ea0eb71b909e
Public Version Date
November 13, 2019
Public Version Number
1
DI Record Publish Date
November 05, 2019
Package DI Number
00653160330939
Quantity per Package
50
Contains DI Package
10653160330936
Package Discontinue Date
-
Package Status
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 | 6043 |
2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
U | Unclassified | 1 |