AccessGUDID - DEVICE: CarbonAid CO2 Diffuser (07340026100029)

GUDID

Device Identifier (DI) Information

Brand Name: CarbonAid CO2 Diffuser
Version or Model: 2800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Cardia Innovation AB

Primary DI Number: 07340026100029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 509120515 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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.

FDA Product Code

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Product Code	Product Code Name
HIF	Insufflator, Laparoscopic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112975	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c6174f63-c2de-4385-b1e6-e178525407c5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 24, 2016