DEVICE: Clarus Endoscopy Pump (B06751691000)

Device Identifier (DI) Information

Clarus Endoscopy Pump
5169-100
In Commercial Distribution
5169-100
CLARUS MEDICAL, LLC
B06751691000
HIBCC

1
010316284 *Terms of Use
Endoscopy Pump
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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
Endoscopic irrigation/aspiration pump A mains electricity (AC-powered) device intended to generate positive and/or negative pressures, to irrigate and/or aspirate a body cavity or lumen with sterile fluid (e.g., saline water) through an endoscope typically to facilitate observation of a site with an endoscope (e.g., during arthroscopy), and/or to keep clear the working channel of an endoscope or lumen of a catheter.
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FDA Product Code

[?]
Product Code Product Code Name
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K912447 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

6d489055-c1e6-48b4-bd4a-67bbc5194a9e
July 06, 2018
3
September 22, 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

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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)

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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
763-525-8400
admin@clarus-medical.com
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