Duns Number:006261481
Device Description: CUSTOM PACK CB9S12R1 2PK BAG
Catalog Number
-
Brand Name
NA
Version/Model Number
CB9S12R1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 24, 2018
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
-
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
ee256f3e-a4ae-45e9-b604-b010b6458737
Public Version Date
December 11, 2018
Public Version Number
4
DI Record Publish Date
April 06, 2017
Package DI Number
20643169984763
Quantity per Package
2
Contains DI Package
00643169984752
Package Discontinue Date
October 24, 2018
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 |