Duns Number:006261481
Device Description: RSVR 1316 MINIMAX INF STD ALN HRDSHL 4PK
Catalog Number
-
Brand Name
Minimax®
Version/Model Number
1316
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
K911789,K911789
Product Code
DTP
Product Code Name
Defoamer, cardiopulmonary bypass
Public Device Record Key
90a2e8be-4708-4574-88d0-67b9309bf1de
Public Version Date
January 22, 2020
Public Version Number
5
DI Record Publish Date
June 09, 2015
Package DI Number
20613994269786
Quantity per Package
4
Contains DI Package
00613994269782
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 |