DEVICE: Safire™ Blu™ Duo SP (05414734311922)

Device Identifier (DI) Information

Safire™ Blu™ Duo SP
A088108
Not in Commercial Distribution
A088108
IRVINE BIOMEDICAL, INC.
05414734311922
GS1
December 18, 2017
1
926346966 *Terms of Use
Ablation Catheter
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry location
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 7 French
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Device Record Status

f7d9b8ef-75d1-4303-b6f5-98ca38e67ca6
March 29, 2018
2
September 29, 2014
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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

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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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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