AccessGUDID - DEVICE: INTELLAGEN™ Tubing Set (04260166374346)

GUDID

Device Identifier (DI) Information

Brand Name: INTELLAGEN™ Tubing Set
Version or Model: 20626
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M004GEN100206260
Company Name: Stockert GmbH

Primary DI Number: 04260166374346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 327536314 *Terms of Use

Device Description: Only commercialized as part of the 10 PK

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):	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?
44772	Cardiac ablation system irrigation tubing set	A collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Premarket Submission

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

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
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 50 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep Dry; Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ea9e5d9-0d5a-41a5-a109-adbb8cd0d5b6
Public Version Date: September 09, 2024
Public Version Number: 1
DI Record Publish Date: September 01, 2024