DEVICE: ECCOVISION Rhinometer (00860719000308)

Device Identifier (DI) Information

ECCOVISION Rhinometer
11000
In Commercial Distribution
11000
SLEEP GROUP SOLUTIONS, LLC
00860719000308
GS1

1
039583619 *Terms of Use
Rhinometer is used for an objective assessment of nasal cavity geometry
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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
Acoustic rhinometer A line-powered (AC-powered), or powered via a connected computer, electronic device designed to allow the internal profile of the nose to be recorded in order to quantify the degree of obstruction/congestion in the nasal cavities and provide monitoring of the consequences of therapy or surgery. A nosepiece conducts a sound pulse produced by an integrated sound generator to the patient?s nose and the sound reflections from the nose are detected where changes in cross-sectional areas are encountered. It is a computer-based device with dedicated software for processing the outgoing and return signals to produce plots of cross-sectional areas as a function of distance in the nose.
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FDA Product Code

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Product Code Product Code Name
BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K921452 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

782ee2f0-2728-4fad-b40e-422e6e3b815f
July 06, 2018
3
September 01, 2016
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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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No
Yes
No
Yes
No CLOSE

Customer Contact

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855-475-3374
swi@qss-llc.com
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