DEVICE: Manual Blood Pressure Monitor (00073796043223)

Device Identifier (DI) Information

Manual Blood Pressure Monitor
HEM-432CN2
In Commercial Distribution

Omron Healthcare, Inc.
00073796043223
GS1

1
054318779 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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
Manual-inflation electronic sphygmomanometer, portable An electronic device, typically digital, designed to noninvasively measure blood pressure using a manually-inflated cuff that typically fits around the arm. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.
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FDA Product Code

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Product Code Product Code Name
DXN System, Measurement, Blood-Pressure, Non-Invasive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K903133 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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

19b0f592-b2cb-4455-abf9-21a18fc4328c
July 06, 2018
3
September 16, 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
10073796043220 12 00073796043223 In Commercial Distribution Case
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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
Yes
No
No
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Customer Contact

[?]
1-800-634-4350
ohiquality@omron.com
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