DEVICE: Pathfinder® CR System (00850006222322)

Device Identifier (DI) Information

Pathfinder® CR System
GI 014CR-1
In Commercial Distribution

NEPTUNE MEDICAL INC.
00850006222322
GS1

1
075588994 *Terms of Use
The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
Yes
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No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60759 Endoscope suction valve, single-use
A device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
FED Endoscopic Access Overtube, Gastroenterology-Urology
FDS Gastroscope And Accessories, Flexible/Rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K240853 000
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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
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

b5525133-0907-40f8-8e9c-ab83a236d82a
July 25, 2024
2
July 09, 2024
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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
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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