Duns Number:006261481
Device Description: ADAP 1036CY SCHRADER Y-BLOCK HOSE ROHS
Catalog Number
-
Brand Name
NA
Version/Model Number
1036CY
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
-
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
P020045
Product Code
LPB
Product Code Name
Cardiac ablation percutaneous catheter
Public Device Record Key
1669de96-94c3-49d9-80e3-b70f248eb6f4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 19, 2015
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |