TempaDOT
TempaDOT Plus F single use Clinical Thermometer with Rectal Sheath
15manufacturers in China registered for this device type
10catalogue 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 |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| 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, case of 1600, case of 6000 |
| Sizes | Weight 0.00046 to 0.0022 lb |
| Distribution end date | 2022-01-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5532 | Weight 0.00143 lb | 100 | In distribution |
| 5125 | Weight 0.00143 lb | 100 | In distribution |
| 5122NS | Weight 0.00143 lb | 100 | In distribution |
| 5124NS | Weight 0.00143 lb | 500 | In distribution |
| 5192R | Weight 0.0022 lb | 100 | In distribution |
| 5502R | Weight 0.0022 lb | 100 | In distribution |
| 5532NS | Weight 0.00143 lb | 100 | In distribution |
| 5122 | Weight 0.00143 lb | 100 | In distribution |
| 5147 | Weight 0.00046 lb | 250 | Withdrawn |
| 5001 | Weight 0.00158 lb | 80 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NexTemp | Medical Indicators, Inc. | 26 |
| Hudson RCI | Teleflex Medical LLC | 10 |
| TraxIt | Medical Indicators, Inc. | 4 |
| 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.