Duns Number:006261481
Device Description: TUBING 3668 3/8x3/32x100 FT NON-STERILE
Catalog Number
-
Brand Name
INTERSEPT®
Version/Model Number
3668
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K924529
Product Code
DWF
Product Code Name
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Public Device Record Key
9611b7b6-da52-4715-a348-b06ac19daf08
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 28, 2016
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 |