Duns Number:938289980
Device Description: A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal de A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.
Catalog Number
000325-011NS
Brand Name
CAP, NON VENTED FEMALE: BLUE NON-STERILE
Version/Model Number
000325-011NS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
DTL
Product Code Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Public Device Record Key
d9b26a8f-67a2-41c0-a61a-3c28c1536b32
Public Version Date
September 23, 2022
Public Version Number
3
DI Record Publish Date
October 13, 2015
Package DI Number
B066000325011NS6
Quantity per Package
30000
Contains DI Package
B066000325011NS1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |