DEVICE: Affinity™ (00763000134556)
Device Identifier (DI) Information
Affinity™
BBAP40
Not in Commercial Distribution
MEDTRONIC, INC.
BBAP40
Not in Commercial Distribution
MEDTRONIC, INC.
PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
31718 | Cardiopulmonary bypass system centrifugal pump |
A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KFM | Pump, blood, cardiopulmonary bypass, non-roller type |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K132712 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: less than 50 Degrees Celsius |
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify: Store the product at room temperature. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
09ed3fb4-38f8-4564-bf20-698035db9f7c
December 09, 2024
2
October 20, 2020
December 09, 2024
2
October 20, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20763000134550 | 4 | 00763000134556 | 2024-11-08 | Not in Commercial Distribution | PK |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com