DEVICE: N/A (04961333229925)

Device Identifier (DI) Information

N/A
7122
In Commercial Distribution

PENTAX OF AMERICA, INC.
04961333229925
GS1

1
083211284 *Terms of Use
EMG Transducers (two channel)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Gastrointestinal motility analysis system, invasive An assembly of devices designed to evaluate peristaltic motility anywhere in the gastrointestinal (GI) tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure on an intraluminal catheter/probe placed in the GI tract. It is intended to record, view, and analyse pH, impedance, pressure, and various other input data (e.g., respirations) to assist in the diagnosis and evaluation of GI motility disorders (e.g., dysphagia). The assembly typically includes a monitor display, computer, software, and dedicated measuring probes.
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FDA Product Code

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Product Code Product Code Name
KLA Monitor, Esophageal Motility, And Tube
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K954798 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bcdaff74-8067-4c06-a4d9-fa53cceff7fc
July 06, 2018
3
April 06, 2017
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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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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