DEVICE: NS 120-TRR Negative Inspiratory Force (NIF) Meter (M996NS120TRR0)
Device Identifier (DI) Information
NS 120-TRR Negative Inspiratory Force (NIF) Meter
NS 120-TRR
In Commercial Distribution
NS 120-TRR
INSTRUMENTATION INDUSTRIES, INCORPORATED
NS 120-TRR
In Commercial Distribution
NS 120-TRR
INSTRUMENTATION INDUSTRIES, INCORPORATED
The Instrumentation Industries, Inc. NS Series Negative Inspiratory Force (NIF) Meters are devices used to measure and monitor patient inspiratory effort. During use the NIF Meter is attached to the patient airway at a point that provides optimal readings of patient respiratory effort.
Federal law restricts these devices to sale by or on the order of a physician.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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? |
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46634 | Airway pressure monitor, non-powered |
A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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BXR | Meter, Airway Pressure (Inspiratory Force) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K081693 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
98cdd081-cc88-499f-b1d8-24f0588d5f00
July 06, 2018
3
July 29, 2016
July 06, 2018
3
July 29, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-412-854-1133
raqa@iiimedical.com
raqa@iiimedical.com