DEVICE: PARA-AID (00819221012002)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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No |
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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60260 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 36 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b639ca63-c18f-4466-aa7e-618e58d358d4
March 29, 2018
2
December 15, 2016
March 29, 2018
2
December 15, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6268399001
yuluw@m-cure.net
yuluw@m-cure.net