Duns Number:041810693
Catalog Number
95707
Brand Name
6 in (15 cm) Q2 T-connector extension set, 2 Q2 T-sites without checkvalves, in-
Version/Model Number
95707
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
K800825,K800825
Product Code
FPK
Product Code Name
Tubing, Fluid Delivery
Public Device Record Key
957e35a3-a92e-4192-bdc1-a88b126387e1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 29, 2016
Package DI Number
20634624957071
Quantity per Package
50
Contains DI Package
00634624957077
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 168 |
U | Unclassified | 8 |