DEVICE: TMC25 (00763000419912)

Device Identifier (DI) Information

TMC25
1473R1
Not in Commercial Distribution

MEDTRONIC, INC.
00763000419912
GS1
November 08, 2024
1
006261481 *Terms of Use
CELL 1473R1 TMC25 W/6 EXTENSION
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
17643 Extracorporeal membrane oxygenator
A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRY MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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
Special Storage Condition, Specify: Store the product at room temperature.
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Clinically Relevant Size

[?]
Size Type Text
Length: 15.2 Centimeter
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Device Record Status

4ddc6414-9e88-49d7-b520-567a59a29147
December 09, 2024
2
September 18, 2021
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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
20763000419916 12 00763000419912 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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