DEVICE: Inquiry™ (05414734305013)

Device Identifier (DI) Information

Inquiry™
AFocus II™
In Commercial Distribution
IBI-81595
IRVINE BIOMEDICAL, INC.
05414734305013
GS1

1
926346966 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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 mapping catheter, percutaneous, single-use 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.
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FDA Product Code

[?]
Product Code Product Code Name
DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K010471 000
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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

a256d75a-85ce-4ddd-9fb7-f42b8ffff6bb
July 06, 2018
3
March 27, 2015
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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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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