DEVICE: NA (00673978522265)
Device Identifier (DI) Information
NA
BT225E
Not in Commercial Distribution
MEDTRONIC, INC.
BT225E
Not in Commercial Distribution
MEDTRONIC, INC.
BOWL BT225E 225ML AUTOTRANSFUSION 9PK
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? |
---|---|---|---|---|
17605 | Autotransfusion system blood component processing set |
A collection of noninvasive devices that typically includes tubing, containers (e.g., bags or bowls for treatment, reinfusion, waste disposal) and filters intended to be used to process (filter/wash) blood components (e.g., red or white blood cells, platelets) in conjunction with a dedicated pump (not included) as part of an autotransfusion procedure; it is not dedicated to suction and/or anticoagulation. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAC | APPARATUS, AUTOTRANSFUSION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K812292 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 50 Degrees Celsius |
Special Storage Condition, Specify: Store in a dry place away from extremes of temperature. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 225 ML Volume |
Device Record Status
7bcfac64-6431-4153-b057-9c25518cb7e0
March 14, 2025
6
June 09, 2015
March 14, 2025
6
June 09, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10673978522262 | 9 | 00673978522265 | 2025-03-11 | 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