Duns Number:008124539
Catalog Number
-
Brand Name
Dead End Stopper & Cap
Version/Model Number
7057
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"
-
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
K172266,K172266,K172266
Product Code
FMG
Product Code Name
Stopcock, I.V. Set
Public Device Record Key
2e8c73b3-70a6-43f8-884b-a0ff71597165
Public Version Date
November 12, 2018
Public Version Number
1
DI Record Publish Date
October 10, 2018
Package DI Number
00616784705736
Quantity per Package
2000
Contains DI Package
00616784705729
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 694 |
2 | A medical device with a moderate to high risk that requires special controls. | 226 |
3 | A medical device with high risk that requires premarket approval | 2 |