Duns Number:006261481
Device Description: RESERVOIR CBMVR800 BIOACT STERILE 6PK
Catalog Number
-
Brand Name
MVR®
Version/Model Number
CBMVR800
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K920774,K920774
Product Code
DTN
Product Code Name
RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
Public Device Record Key
ec1d7324-57be-47b0-91d5-3c6bd567aa29
Public Version Date
January 22, 2020
Public Version Number
4
DI Record Publish Date
June 17, 2016
Package DI Number
20613994931010
Quantity per Package
6
Contains DI Package
00613994931016
Package Discontinue Date
November 30, 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 |