DEVICE: HeartLight (00859373007440)

Device Identifier (DI) Information

HeartLight
18-4952
In Commercial Distribution
18-4952
CARDIOFOCUS, INC.
00859373007440
GS1

1
068966261 *Terms of Use
HeartLight X3 Console, US
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61969 Cardiac ablation solid-state laser system
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a doped glass/crystal medium to emit a high-power laser beam intended for endocardial ablation procedures for the treatment of atrial fibrillation; the therapeutic laser does not include frequency-doubling technology. It includes a laser generator with controls and monitor. It is intended to function with a laser beam-guide catheter (typically introduced to the pulmonary vein via transseptal access) and a flexible video angioscope for visualization during the procedure; the catheter and angioscope may be included.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OAE Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P150026 008
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -25 and 55 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4252a5d3-76b8-486d-a030-2a677d1299c1
May 27, 2020
1
May 19, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(844)527-3723
customerservice@cardiofocus.com
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