Duns Number:006261481
Device Description: HANDCRANK 95183-001 BIOCONSOLE1EA 150
Catalog Number
-
Brand Name
NA
Version/Model Number
95183-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2015
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
-
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
K926357
Product Code
DWA
Product Code Name
Control, pump speed, cardiopulmonary bypass
Public Device Record Key
fdc8545c-131a-4dca-96ba-d49016105ed1
Public Version Date
September 22, 2022
Public Version Number
4
DI Record Publish Date
June 18, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |