Adtemp™
ADTEMP 418 Digital Thermometer, Flex-tip, Lrg Disp, 8 sec, BMWS-5 sheaths
115manufacturers in China registered for this device type
35catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (68), Zhejiang (15), Jiangsu (13). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 36 |
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Famidoc Technology Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
Showing 12 of 115. All 115 manufacturers in China registered for Continuous Measurement Thermometer
Record
| Listed by | American Diagnostic Corp., United States |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K940686 |
| Record published | 2017-12-01 |
| Record revised | 2026-02-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -13 to 140 °F |
| Packaging | Master case of 12, inner pack of 12, inner pack of 6, master case of 8, master case of 20, master case of 4 |
| Distribution end date | 2019-04-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 413BCN | In distribution | ||
| 412-00 | In distribution | ||
| 418N | In distribution | ||
| 427 | In distribution | ||
| 416-100 | In distribution | ||
| 425-40 | 40 | In distribution | |
| 413R-00 | In distribution | ||
| 413B | In distribution | ||
| 416-1000 | In distribution | ||
| 415K | In distribution | ||
| 413RQ | In distribution | ||
| 429CRADLE | In distribution | ||
| 413B-00 | In distribution | ||
| 424 | In distribution | ||
| 415FL | In distribution | ||
| 417 | In distribution | ||
| 416-50 | In distribution | ||
| 413BRKIT | In distribution | ||
| 416-5000 | In distribution | ||
| 412K | In distribution | ||
| 413BK | In distribution | ||
| 424N-200 | 200 | In distribution | |
| 429 | In distribution | ||
| 427Q | In distribution | ||
| 413BQ | In distribution | ||
| 413R | In distribution | ||
| 433EU | In distribution | ||
| 413RK | In distribution | ||
| 421 | In distribution | ||
| 424N | In distribution | ||
| 424N-40 | 40 | In distribution | |
| 422 | In distribution | ||
| 415 | Withdrawn | ||
| 418 | Withdrawn | ||
| 424CN | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 434 |
| Safety 1st | Dorel Juvenile Group, Inc. | 180 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Diagnostix™ | American Diagnostic Corp. | 61 |
| DeRoyal | Deroyal Industries, Inc. | 58 |
| Braun | KAZ USA, Inc. | 53 |
| Exergen Temporal Scanner | Exergen Corporation | 50 |
| Level 1 | ICU Medical, Inc | 48 |
| Famidoc | Famidoc Technology Co., Ltd. | 47 |
| TempTraq | Blue Spark Technologies, Inc. | 35 |
| Medline | Medline Industries, Inc. | 34 |
| Mabis | D-M-S Holdings, Inc. | 34 |
Showing 12 of 843. All products under Continuous Measurement Thermometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K940686 | 1994-07-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Omron Healthcare, Inc. | 510(k) number | 2005-10-25 | Not classified | Other | Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip. | Approximately 48,000 units | 2007-11-28 |
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.