Duns Number:006261481
Device Description: SUCKER CB5032 2PK COATED
Catalog Number
-
Brand Name
INTERSEPT®
Version/Model Number
CB5032
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 25, 2017
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
K891687,K891687
Product Code
DTZ
Product Code Name
OXYGENATOR, CARDIOPULMONARY BYPASS
Public Device Record Key
65b36c4d-1b04-436d-bb60-392e19a3ac36
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 19, 2015
Package DI Number
20681490469320
Quantity per Package
2
Contains DI Package
00681490469326
Package Discontinue Date
August 25, 2017
Package Status
Not 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 |