Duns Number:058027475
Device Description: Luer Lock Extension Set with Check Valve & a Safti-Ject SV Swabable Valve Needleless Conne Luer Lock Extension Set with Check Valve & a Safti-Ject SV Swabable Valve Needleless Connector
Catalog Number
-
Brand Name
Safti-Ject SV
Version/Model Number
BC 7034
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
2270fc35-3c6b-420b-91e1-86b6f263d41b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 31, 2017
Package DI Number
00813153024409
Quantity per Package
1
Contains DI Package
10813153024406
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 381 |