CarbonAid CO2 Diffuser

GUDID 27340026100023

Cardia Innovation AB

Surgical wound insufflation set

• Primary Device ID: 27340026100023
• NIH Device Record Key: c6174f63-c2de-4385-b1e6-e178525407c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarbonAid CO2 Diffuser
• Version Model Number: 2800
• Company DUNS: 509120515
• Company Name: Cardia Innovation AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340026100029 [Primary]
GS1	17340026100026 [Package]; Contains: 07340026100029; Package: [8 Units]; In Commercial Distribution
GS1	27340026100023 [Package]; Contains: 17340026100026; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112975

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-24

Devices Manufactured by Cardia Innovation AB

• 27340026100023 - CarbonAid CO2 Diffuser: 2018-07-06
• 27340026100023 - CarbonAid CO2 Diffuser: 2018-07-06
• 27340026114006 - CarbonMini CO2 Diffuser: 2018-07-06