FDA UDI
In Commercial Distribution
🇺🇸 United States
Health-Tec Biological Monitoring System
DI: D773590HT52BMS1
·
Model: 590-HT52BMS
·
Dental Health Products Inc
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
52
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Health-Tec Biological Monitoring System
- Primary DI
- D773590HT52BMS1
- Version / Model
- 590-HT52BMS
- Catalog Number
- 590-HT52BMS
- Company Name
- Dental Health Products Inc
- Labeler DUNS
- 623191194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 52
- Record Status
- Published
- Publish Date
- 2017-01-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b8e3ee8e-d01d-4fe7-a6d6-fc8270f10d6d
Device Description
Health-Tec Biological Monitoring System, Mail-In 2-Strip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRB | Indicator, Biological, Liquid Chemical Sterilization Process | General Hospital | 880.2800 | 2 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D773590HT52BMS1 | HIBCC | ||||
| Unit of Use | D773590HT52BMS0 | HIBCC | ||||
| Package | D773590HT52BMS3 | HIBCC | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-626-2163
- [email protected]