AccessGUDID - DEVICE: CarbonMini CO2 Diffuser (07340026114002)

GUDID

Device Identifier (DI) Information

Brand Name: CarbonMini CO2 Diffuser
Version or Model: 1400
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Cardia Innovation AB

Primary DI Number: 07340026114002
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42977	Surgical wound gas diffuser	A device designed for controlled diffusion of a medical gas [e.g., carbon dioxide (CO2), humidified air] into an open surgical wound during an open surgical gas insufflation procedure, typically to minimize the risk of air embolism or reduce heat transfer from the surgical wound. The diffuser typically includes connection tubing and may also include a filter. This is a single-use device.	Active	false

FDA Product Code

[?]

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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa7bc714-5e8d-4a25-9ba9-1920e114551b
Public Version Date: September 20, 2021
Public Version Number: 4
DI Record Publish Date: 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
27340026114006	3	17340026114009		In Commercial Distribution
17340026114009	8	07340026114002		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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