DEVICE: Ampere™ (05415067004987)

Device Identifier (DI) Information

Ampere™
Footswitch
In Commercial Distribution
H700498
ST. JUDE MEDICAL, INC.
05415067004987
GS1

1
149818952 *Terms of Use
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
Foot-switch, electrical An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.
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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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FDA Premarket Submission

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

Sterilization

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

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

[?]
Size Type Text
Length: 2.5 Meter
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Device Record Status

2921e2ac-036f-4d88-bc87-5e515b0b6b8e
March 29, 2018
2
February 05, 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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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