AirLife™
AirLife™ Tempo2-I™ Thermometer with U/Adapt-It™ Straight Connector 004086 (Both Arms 22 mm OD)
15manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
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 | Airlife, Inc., United States |
|---|---|
| FDA product code | FQZ |
| Device type | Thermometer, Clinical Color Change |
| Device class | Class 1 |
| Regulation | 21 CFR 880.2900 |
| Premarket notification | Exempt |
| Record published | 2025-03-27 |
| Record revised | 2025-04-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 001951 | In distribution | |
| 001955 | In distribution | |
| 001952 | 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 |
| TraxIt | Medical Indicators, Inc. | 4 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K790890 | 1979-06-27 |
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.