AccessGUDID - DEVICE: andorate® CO2 Source Tubing Adapter (04897106952748)

GUDID

Device Identifier (DI) Information

Brand Name: andorate® CO2 Source Tubing Adapter
Version or Model: GAR108
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GA Health Company Limited

Primary DI Number: 04897106952748
Issuing Agency: GS1
Commercial Distribution End Date: August 29, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 686908512 *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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
62063	Endoscopic insufflation tubing set, reusable	A collection of flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: 37429c0c-5456-40c9-9b00-14d15572f49e
Public Version Date: August 31, 2023
Public Version Number: 6
DI Record Publish Date: August 10, 2020