TraxIt
TraxIt F DTC Wearable Children's Underarm Single-use Thermometer (48-Hour Continuous Monitoring)
15manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Zhejiang (3).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Shanghai Dynamic Medical Supplies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 37 |
| China (Shenyang) MED-Land IMP/EXP Corp., Ltd. | Shanghai | Shanghai | Exporter | 32 |
| GFA Production Xiamen Co., Ltd. | Tong An, Xiamen | Fujian | Repacker / relabeller | 30 |
| Medical Distribution Industries, Ltd. | Kowloon | Exporter | 27 |
Showing 12 of 15. All 15 manufacturers in China registered for Thermometer, Clinical Color Change
Record
| Listed by | Medical Indicators, Inc., United States |
|---|---|
| FDA product code | FQZ |
| Device type | Thermometer, Clinical Color Change |
| Device class | Class 1 |
| Regulation | 21 CFR 880.2900 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-29 |
| Record revised | 2025-07-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 30 °C |
| Packaging | Case of 2000 |
| Sizes | Weight 0.00123 lb |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2313 | Weight 0.00123 lb | 100 | In distribution |
| 4001-12 | Weight 0.00123 lb | 12 | In distribution |
| 1313 | Weight 0.00123 lb | 100 | In distribution |
| 2313-12 | Weight 0.00123 lb | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NexTemp | Medical Indicators, Inc. | 26 |
| Hudson RCI | Teleflex Medical LLC | 10 |
| TempaDOT | Medical Indicators, Inc. | 10 |
| AirLife™ | Airlife, Inc. | 3 |
| Dr.Tempzone+ | ONE Power | 2 |
| AirLife™ | Vyaire Medical, Inc. | 1 |
| Wrootbol Notipatch | ONE Power | 1 |
| Titronics | Titronics Research & Development | 1 |
| Arrow | Teleflex Medical LLC | 1 |
| Quick Temp Pro Infrared Thermometer | Home Aide Diagnostics, Inc. | 1 |
| I-MED Non-Contact Infrared digital Clinical Thermometer | I-MED Pharma Inc. | 1 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-07-10 | Class II | Labeling mix-ups | TempaDot products may have been mislabeled. | 111,800 boxes (5,590 full boxes) | 2014-01-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.