Duns Number:006261481
Device Description: CON CB4617 INTSPT BIOACT 3/16X3/16LL10PK
Catalog Number
-
Brand Name
Intersept™
Version/Model Number
CB4617
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171979,K171979
Product Code
DTZ
Product Code Name
OXYGENATOR, CARDIOPULMONARY BYPASS
Public Device Record Key
125f27e3-65b4-430b-a6ab-08e4896c8251
Public Version Date
March 09, 2020
Public Version Number
1
DI Record Publish Date
March 01, 2020
Package DI Number
20763000218472
Quantity per Package
10
Contains DI Package
00763000218478
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| 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 |