DEVICE: CarbonAid CO2 Diffuser (07340026100029)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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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. |
FDA Product Code
[?]Product Code | Product Code Name |
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HIF | Insufflator, Laparoscopic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K112975 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c6174f63-c2de-4385-b1e6-e178525407c5
July 06, 2018
3
August 24, 2016
July 06, 2018
3
August 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]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 |
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
[?]
No Customer Contact currently defined