DEVICE: Affinity™ (00763000134556)

Device Identifier (DI) Information

Affinity™
BBAP40
Not in Commercial Distribution

MEDTRONIC, INC.
00763000134556
GS1
November 08, 2024
1
006261481 *Terms of Use
PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
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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
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FDA Product Code

[?]
Product Code Product Code Name
KFM Pump, blood, cardiopulmonary bypass, non-roller type
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K132712 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

09ed3fb4-38f8-4564-bf20-698035db9f7c
December 09, 2024
2
October 20, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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