DEVICE: Agilis™ NxT (05414734217972)

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Device Identifier (DI) Information

Agilis™ NxT
G408332
G408332
ST. JUDE MEDICAL, INC.
05414734217972
GS1
1
No description.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Cardiovascular device introducer, steerable A sterile, steerable, tubular sheath designed for percutaneous placement in/near the cardiovascular system and through which other cardiovascular devices (e.g., cardiac/intravascular catheter, pacing lead) are subsequently inserted for positioning in blood vessels, heart chambers, or on epicardial surfaces. The distal tip is actuated via controls at the proximal end to accommodate manoeuvring in/around the heart. It may be fitted with a haemostasis valve (HV) to minimize blood loss during intervention [e.g., electrophysiology (EP)], a sideport for aspiration/infusion/blood sampling, have radiopaque markings, and may include a dedicated intraluminal dilator. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DQB PHLEBOGRAPH, IMPEDANCE
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
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Clinically Relevant Size

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Size Type Text
Catheter Gauge: 8.5 French
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Device Status

In Commercial Distribution
March 06, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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