DEVICE: Ampere™ (05415067004901)

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Device Identifier (DI) Information

Ampere™
Remote Control
H700490
ST. JUDE MEDICAL, INC.
05415067004901
GS1
1
No description.
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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
Medical device remote control keypad A hand-operated panel (a keypad) with a configuration of push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of a parent medical device (e.g., patient monitor) typically through a connected cable or infrared (IR) transmission.
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FDA Product Code

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Product Code Product Code Name
LPB Cardiac ablation percutaneous catheter
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Sterilization

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

[?]
Storage and Handling
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 60 Degrees Celsius
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry.
Storage Environment Temperature: between -25 and 60 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
February 05, 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

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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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