Duns Number:080914995
Catalog Number
-
Brand Name
Smart Connector
Version/Model Number
Smart Connector
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K981613,K981613
Product Code
DTL
Product Code Name
ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
Public Device Record Key
1cbe4876-f1fc-4861-b89a-cefad4b1b1c1
Public Version Date
August 15, 2018
Public Version Number
4
DI Record Publish Date
May 19, 2015
Package DI Number
10803622124966
Quantity per Package
10
Contains DI Package
00803622124969
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 44 |
2 | A medical device with a moderate to high risk that requires special controls. | 479 |
3 | A medical device with high risk that requires premarket approval | 30 |