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
05060912587483
GS1

1
236289299 *Terms of Use
05060491619810
The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
DTZ Oxygenator, Cardiopulmonary Bypass
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
DTR Heat-Exchanger, 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

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Storage and Handling
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.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7c35cbad-ed9f-4dee-8abe-cf7957f73107
February 17, 2025
1
February 07, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15060912587480 3 05060912587483 In Commercial Distribution
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+440190917077
enquiries@chalicemedical.com
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