Duns Number:625272232
Device Description: 5 male luers with one 20cm SCD Tube and pinch clamp
Catalog Number
-
Brand Name
Cell Connect
Version/Model Number
CC35-5MT
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
-
Product Code
KJG
Product Code Name
Tube, Tissue Culture
Public Device Record Key
347eac3a-242b-4801-8196-bb5f52147167
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
January 25, 2017
Package DI Number
20816203023173
Quantity per Package
12
Contains DI Package
10816203023176
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 44 |