DEVICE: Health-Tec Biological Monitoring System (D773590HT12BMS1)

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Device Identifier (DI) Information

Health-Tec Biological Monitoring System
590-HT12BMS
590-HT12BMS
Dental Health Products Inc
D773590HT12BMS1
HIBCC
12
Health-Tec Biological Monitoring System, Mail-In 2-Strip
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
No
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
Biological sterilization indicator A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MRB Indicator, Biological, Liquid Chemical Sterilization Process
FRC Indicator, Biological Sterilization Process
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
January 24, 2017

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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
D773590HT12BMS3 6 D773590HT12BMS1 In Commercial Distribution
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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: D773590HT12BMS0 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-626-2163
mhull@dhpi.net
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