FDA UDI
In Commercial Distribution
🇺🇸 United States
TempTraq®
DI: 00851203006364
·
Model: 4.x.x
·
BLUE SPARK TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TempTraq®
- Primary DI
- 00851203006364
- Version / Model
- 4.x.x
- Company Name
- BLUE SPARK TECHNOLOGIES, INC.
- Labeler DUNS
- 603031365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-25
- Public Version
- 2
- Public Version Date
- 2026-03-13
- Public Version Status
- Update
- Public Device Record Key
- 5e4d465b-3f64-4bf3-ae4a-3237f269c7a3
Device Description
TempTraq Patient Android App
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62169 | Wireless patient monitor/sensor reporting software, layperson-use | A software program intended to be used by a layperson at home to receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting of the collected clinical data, typically for continuous monitoring and optional communication with a clinician. It may enable configuration of alert notifications and is typically installed on an off-the-shelf, portable, computerized device (e.g., smartphone, tablet); it is not dedicated to bedside monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851203006364 | GS1 |
Customer Contacts
- Phone
- 14402495440
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201977 | 000 |