Duns Number:006261481
Device Description: OXYGENATOR CB3381 BIOACT MINIMAX S 4PKL
Catalog Number
-
Brand Name
MINIMAX®
Version/Model Number
CB3381
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 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
K933586,K933586
Product Code
DTZ
Product Code Name
OXYGENATOR, CARDIOPULMONARY BYPASS
Public Device Record Key
8d4e2895-60e6-485a-9c90-709d2d236dc5
Public Version Date
January 22, 2020
Public Version Number
5
DI Record Publish Date
June 09, 2015
Package DI Number
20613994965138
Quantity per Package
4
Contains DI Package
00613994965134
Package Discontinue Date
October 05, 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 |