AccessGUDID - DEVICE: DiamondTemp™ Bidirectional Ablation Catheter (00763000536671)

GUDID

Device Identifier (DI) Information

Brand Name: DiamondTemp™ Bidirectional Ablation Catheter
Version or Model: CEDTB400L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000536671
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: BIDIR CATH LG CURVE CEDTB400L US

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?
61785	Cardiac radio-frequency ablation system catheter	A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200028	020

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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Catheter tip size 2.50mm (7.5Fr)
Catheter Length: 110.0 Centimeter
Device Size Text, specify: Electrode spacing between distal ring electrode and proximal ring electrode 2mm
Device Size Text, specify: Ring electrode length 1.3mm
Device Size Text, specify: Distal electrode length .6mm
Outer Diameter: 2.67 Millimeter
Device Size Text, specify: Composite tip electrode length 4.1mm
Tip Bend Radius: 63.0 Millimeter
Device Size Text, specify: Electrode spacing between composite electrode and distal ring electrode 3.5mm
Device Size Text, specify: Electrode spacing between distal electrode and proximal electrode .5mm

Device Record Status

Public Device Record Key: 9b616cfe-f68b-469a-bf14-11b1031df2b3
Public Version Date: January 08, 2024
Public Version Number: 1
DI Record Publish Date: December 30, 2023