Model: OPTI-CATH2-60
DI: 00850064686166
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Generation 2 OptiMap catheter, 60 mm diameter
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3062a604-58cb-4fab-92bf-6cbf929a032e
Distribution Status:
In Commercial Distribution
DUNS Number:
119228234
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850064686166
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46355
Name: Cardiac mapping catheter, percutaneous, single-use
Definition:
A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.
FDA Product Codes
MTD
Catheter, Intracardiac Mapping, High-Density Array
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
2
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
25
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
85
Item #2 - Storage Handling Type:
Handling Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
-29
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
50
Item #3 - Storage Handling Type:
Handling Environment Temperature