Duns Number:053146767
Device Description: The ADP 150 Hose Connector: Dimensions - 15mm O.D. x 1/2" O/D. Reusable.
Catalog Number
ADP 150
Brand Name
ADP 150 Hose Connector
Version/Model Number
ADP 150
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
e70266dc-c583-4735-89a8-e7690e7541c6
Public Version Date
May 20, 2019
Public Version Number
1
DI Record Publish Date
May 11, 2019
Package DI Number
M996ADP1505
Quantity per Package
50
Contains DI Package
M996ADP1500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |