Duns Number:089055867
Device Description: TUBING 27756 CATHCONNECT STD BI 8CM 5PK
Catalog Number
-
Brand Name
N/A
Version/Model Number
27756
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
K792005,K792005
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
c90cf0e5-b264-4cff-8d3d-716d0f68b028
Public Version Date
October 10, 2022
Public Version Number
2
DI Record Publish Date
March 20, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 1465 |