CarbonMini CO2 Diffuser

GUDID 27340026114006

Cardia Innovation AB

Surgical wound insufflation set Surgical wound gas diffuser Surgical wound gas diffuser Surgical wound gas diffuser Surgical wound gas diffuser Surgical wound gas diffuser Surgical wound gas diffuser Surgical wound gas diffuser Surgical wound gas diffuser Surgical wound gas diffuser

• Primary Device ID: 27340026114006
• NIH Device Record Key: aa7bc714-5e8d-4a25-9ba9-1920e114551b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarbonMini CO2 Diffuser
• Version Model Number: 1400
• 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	07340026114002 [Primary]
GS1	17340026114009 [Package]; Contains: 07340026114002; Package: [8 Units]; In Commercial Distribution
GS1	27340026114006 [Package]; Contains: 17340026114009; 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
• 27340026114006 - CarbonMini CO2 Diffuser: 2018-07-06
• 27340026114006 - CarbonMini CO2 Diffuser: 2018-07-06