Duns Number:809699023
Device Description: Male Luer Lock Fitting for SOSA Tubing
Catalog Number
-
Brand Name
NAMIC
Version/Model Number
80800003
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
K842829,K842829
Product Code
DTL
Product Code Name
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Public Device Record Key
45b166d2-05eb-4c11-b0d4-3867799ec824
Public Version Date
December 03, 2019
Public Version Number
2
DI Record Publish Date
October 01, 2019
Package DI Number
H965808000031
Quantity per Package
5000
Contains DI Package
H965808000030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |