DEVICE: ViewMate™ (05415067013361)

Device Identifier (DI) Information

ViewMate™
H701336
In Commercial Distribution
H701336
ST. JUDE MEDICAL, INC.
05415067013361
GS1

1
149818952 *Terms of Use
Ultrasound Console
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Ultrasound imaging cardiac catheter, steerable, single-use A sterile, steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and/or intraluminal visualization to assess cardiac anatomy and physiology, as well as visualization of other devices in the heart. It is introduced percutaneously with the distal tip actuated by the operator using controls at the proximal end to accommodate manoeuvring in the cardiac anatomy. It is connected to a compatible ultrasound system for transmission and display of the images. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DRJ SYSTEM, SIGNAL ISOLATION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry.
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Clinically Relevant Size

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

8d536ff4-7a50-4251-9183-ba8ef137d247
March 29, 2018
2
April 25, 2016
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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(855)478-5833
customerservice@sjm.com
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