Duns Number:078603710
Device Description: Steripath Blood Collection System, Sterile Pack, Luer, Wide Neck TA
Catalog Number
2700-EN
Brand Name
SteriPath Gen2, Luer
Version/Model Number
2700-EN
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
K192247,K192247
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
1c49b1f6-5c69-4d2e-9106-47ff2a4d304f
Public Version Date
October 27, 2021
Public Version Number
2
DI Record Publish Date
November 06, 2020
Package DI Number
10858366007006
Quantity per Package
10
Contains DI Package
00858366007009
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Sales Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 15 |