DEVICE: Novii (05060433670060)

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Device Identifier (DI) Information

Novii
107-PT-003

MONICA HEALTHCARE LIMITED
05060433670060
GS1
1
Novii Pod
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Device Characteristics

MR Unsafe
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
Foetal cardiac monitor A mains electricity (AC-powered) device designed to detect, measure, and display foetal heart activity during the perinatal period. Typically foetal heart rate is measured, but heart valve movement can also be assessed. The device operates noninvasively by: 1) electronically registering and graphically presenting foetal heart sounds; 2) discriminating foetal and maternal electrocardiographic signals obtained from the maternal abdomen with external electrodes; or 3) transmitting and receiving ultrasonic energy into and from the pregnant woman usually by means of continuous wave (Doppler) echoscopy. The device may include an alarm that signals when the heart rate crosses a pre-set threshold.
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FDA Product Code

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Product Code Product Code Name
OSP Uterine Electromyographic Monitor
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 12, 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
35060433670061 3 05060433670060 In Commercial Distribution Carton
25060433670064 2 05060433670060 In Commercial Distribution Carton
15060433670067 1 05060433670060 In Commercial Distribution Carton
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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)

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

[?]
Yes
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1 877-320-5174
info@monicahealthcare.com
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