Level 1
48 catalogue numbers from STS-201, listed by ICU Medical, Inc, United States, under Continuous Measurement Thermometer. 115 manufacturers in China are registered for this product code.
115manufacturers in China registered for this device type
48catalogue numbers in this listing
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 | ICU Medical, Inc, United States |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K864195 |
| Record published | 2016-10-11 |
| Record revised | 2025-04-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 100, case of 200, case of 20, box of 20, box of 200, box of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STS-201 | In distribution | |
| MTS-40030 | In distribution | |
| STS-70S | In distribution | |
| C400-5 | In distribution | |
| ER400-9 | In distribution | |
| C204-3 | In distribution | |
| C70S-10 | In distribution | |
| C203-10 | In distribution | |
| C400-15 | In distribution | |
| TTSP-400 | In distribution | |
| STS-205 | In distribution | |
| STS-202 | In distribution | |
| C202-3 | In distribution | |
| TTSP-TC | In distribution | |
| STS-204 | In distribution | |
| C400-10HPSP | In distribution | |
| C400-15HP | In distribution | |
| MTS-4008 | In distribution | |
| STS-TC | In distribution | |
| C400-10 | In distribution | |
| C205-3D | In distribution | |
| C400-20HP | In distribution | |
| C207-3 | In distribution | |
| TTS-TC | In distribution | |
| C400-10HP | In distribution | |
| MTS-40015 | In distribution | |
| STS-207 | In distribution | |
| STS-206 | In distribution | |
| C201-3 | In distribution | |
| ERTC-12 | In distribution | |
| C205-3 | In distribution | |
| STS-700 | In distribution | |
| C400-10KT | In distribution | |
| C206-3 | In distribution | |
| C203-3 | In distribution | |
| STS-209 | In distribution | |
| C209-10 | In distribution | |
| C400-10SP | In distribution | |
| STS-203 | In distribution | |
| ER700-9 | In distribution | |
| STS-400 | In distribution | |
| ER700-12 | In distribution | |
| C700-10 | In distribution | |
| C201-10 | In distribution | |
| TTS-400 | In distribution | |
| ER70S-9 | In distribution | |
| ER400-12 | In distribution | |
| C204-10 | In distribution |
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 |
| Famidoc | Famidoc Technology Co., Ltd. | 47 |
| Adtemp™ | American Diagnostic Corp. | 35 |
| 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | 510(k) number | 2006-03-08 | Not classified | Other | Product temperature readings may be 2C higher than the actual temperature | 20,000 | 2012-05-30 |
| Smiths Medical Asd, Inc. | 510(k) number | 2006-03-08 | Not classified | Other | Product temperature readings may be 2C higher than the actual temperature | 400 | 2012-05-30 |
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.