Duns Number:008124539
Catalog Number
-
Brand Name
8945 SecureSafe Safety Blood Collection Set w/ Tube Holder, 25G, 3/4" Needle, 4/
Version/Model Number
8945
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151991,K151991
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
4ffc30b5-3d94-4785-a8a0-c99ccfd80ef3
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
September 13, 2018
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 | 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 |