DEVICE: PARA-AID (00819221012002)

Device Identifier (DI) Information

PARA-AID
0001
In Commercial Distribution

McUre Health Solutions, Inc.
00819221012002
GS1

1
053034873 *Terms of Use
Pregnancy Test
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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/maternal multiple physiological parameter simulation kit A collection of portable devices intended to imitate a variety of physiological parameters and conditions (both foetal and maternal) expressed during pregnancy (e.g., TOCO, uterine and foetal heart activity) in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers. It typically includes a foetal/maternal multiple physiological parameter simulator, a foetal heart simulator, and connection cables. This device is intended to be used by a healthcare provider in a clinical setting.
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FDA Product Code

[?]
Product Code Product Code Name
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 36 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b639ca63-c18f-4466-aa7e-618e58d358d4
March 29, 2018
2
December 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
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
No
Yes
Yes
No CLOSE

Customer Contact

[?]
6268399001
yuluw@m-cure.net
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