DEVICE: CMO8 Adult PMP Oxygenator with Tubing Pack (05060912587483)
Device Identifier (DI) Information
CMO8 Adult PMP Oxygenator with Tubing Pack
CME40009
In Commercial Distribution
CME40009
CHALICE MEDICAL LIMITED
CME40009
In Commercial Distribution
CME40009
CHALICE MEDICAL LIMITED
The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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62085 | Extracorporeal membrane oxygenation system circuit |
A complete portable assembly of noninvasive, non-powered devices intended to be used as part of an extracorporeal bypass system to provide short-term or prolonged (i.e., extra-surgical) mechanical circulatory life support during extracorporeal membrane oxygenation (ECMO) [sometimes referred to as extracorporeal lung support (ECLS)]. It usually includes a centrifugal pump mechanism, defoamer, heat exchanger, membrane oxygenator, and integrated tubing or independent tubing sets. It is intended to be used in conjunction with the capital components (e.g., pump drive unit, gas control unit, heating/cooling unit) and invasive components (e.g., cannulae) of the bypass. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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DTZ | Oxygenator, Cardiopulmonary Bypass |
DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
DTR | Heat-Exchanger, Cardiopulmonary Bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 5 and 23 Degrees Celsius |
Special Storage Condition, Specify: to be stored in a dry, room temperature area and protected from direct solar or UV light. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7c35cbad-ed9f-4dee-8abe-cf7957f73107
February 17, 2025
1
February 07, 2025
February 17, 2025
1
February 07, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
15060912587480 | 3 | 05060912587483 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+440190917077
enquiries@chalicemedical.com
enquiries@chalicemedical.com