Affinity®
The FDA filing identifies the Affinity Temperature Probe and lists ATP210 among its models. The probe is described with a thermistor sensor in a stainless steel sheath and a 3 metre cable…
The FDA filing identifies the Affinity Temperature Probe and lists ATP210 among its models. The probe is described with a thermistor sensor in a stainless steel sheath and a 3 metre cable ending in a phono plug.
Its stated use is continuous blood temperature monitoring through a temperature monitoring adapter in a compatible Medtronic extracorporeal circulation device. The filing also describes use with a YSI tele-thermometer to monitor and display temperature.
Listed Item
Probe ATP210 Affinity Temperature WW
Probe Connection
The comparison table lists ATP210 under the Affinity Temperature Probe models. The probe connects through the adapter specified for the compatible circulation device.
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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K160091 |
| Record published | 2016-09-24 |
| Record revised | 2023-08-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature -30 to 57 °C |
| Distribution end date | 2018-10-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ATP210 | In distribution | |
| ATP210 | In distribution | |
| ATP210 | In distribution | |
| ATP210 | 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 |
| Adtemp™ | American Diagnostic Corp. | 35 |
| TempTraq | Blue Spark Technologies, Inc. | 35 |
| Medline | Medline Industries, Inc. | 34 |
Showing 12 of 843. All products under Continuous Measurement Thermometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160091 | 2016-05-20 |
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.