AccessGUDID - DEVICE: Health-Tec Biological Monitoring System (D773590HT52BMS1)

GUDID

Device Identifier (DI) Information

Brand Name: Health-Tec Biological Monitoring System
Version or Model: 590-HT52BMS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 590-HT52BMS
Company Name: Dental Health Products Inc

Primary DI Number: D773590HT52BMS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 52
Labeler D-U-N-S® Number*: 623191194 *Terms of Use

Device Description: Health-Tec Biological Monitoring System, Mail-In 2-Strip

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13732	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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b8e3ee8e-d01d-4fe7-a6d6-fc8270f10d6d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 24, 2017