DEVICE: CarbonAid CO2 Diffuser (07340026100029)

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Device Identifier (DI) Information

CarbonAid CO2 Diffuser
2800

Cardia Innovation AB
07340026100029
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Surgical wound insufflation set A collection of devices designed to diffusely insufflate carbon dioxide (CO2) into an open surgical wound to reduce the risk of air embolism. It is typically used to insufflate the thoracic cavity during open heart surgery procedures. It typically includes tubing to connect the CO2 source with a gas diffuser (typically made of foam) placed into the wound, connectors, and a gas filter to prevent cross-contamination between the gas source/humidifier and the wound. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HIF Insufflator, Laparoscopic
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 24, 2016

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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
27340026100023 3 17340026100026 In Commercial Distribution
17340026100026 8 07340026100029 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
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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