Duns Number:089055867
Device Description: RESERVOIR 44104 VENT. INLET BOTTOM
Catalog Number
-
Brand Name
N/A
Version/Model Number
44104
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
K833822
Product Code
LKG
Product Code Name
Port & catheter, implanted, subcutaneous, intraventricular
Public Device Record Key
7f32579a-a994-4f3c-95ce-1694f6a4e23c
Public Version Date
March 30, 2020
Public Version Number
1
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 |