DEVICE: Safire™ TX (05414734300193)

Device Identifier (DI) Information

Safire™ TX
402843
In Commercial Distribution
402843
IRVINE BIOMEDICAL, INC.
05414734300193
GS1

1
926346966 *Terms of Use
Ablation Catheter
CLOSE

Device Characteristics

MR Unsafe
No
No
Yes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P040042 009
P040042 052
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 7 French
CLOSE

Device Record Status

ee2bede7-e034-4cde-b7ce-6eff5eaf63cd
February 21, 2023
4
September 29, 2014
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
CLOSE