DEVICE: NS 60-TRR Negative Inspiratory Force (NIF) Meter (M996NS60TRR0)

Device Identifier (DI) Information

NS 60-TRR Negative Inspiratory Force (NIF) Meter
NS 60-TRR
In Commercial Distribution
NS 60-TRR
INSTRUMENTATION INDUSTRIES, INCORPORATED
M996NS60TRR0
HIBCC

1
053146767 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
BXR Meter, Airway Pressure (Inspiratory Force)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K081693 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

b24f0fec-cd9c-4dfa-998e-2a50a8ff6959
July 06, 2018
3
July 29, 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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Yes
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No
No CLOSE

Customer Contact

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1-412-854-1133
raqa@iiimedical.com
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