TempTrend
2 catalogue numbers from 1000, listed by Biosynergy, Inc., United States, under Strip, Temperature, Forehead, Liquid Crystal. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (5), Zhejiang (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Suzhou Pipi Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Dongyang City Yonoel Outdoor Products Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 32 |
| Essentia Industries Ltd. | Dong Guan | Guangdong | Contract manufacturer | 31 |
| Suzhou Pulikang Medical Device Co Ltd | Suzhou | Jiangsu | Remanufacturer | 26 |
| Rfx+care Manufacturing Co., Ltd. | Shaoxing | Zhejiang | Repacker / relabeller | 21 |
Showing 12 of 17. All 17 manufacturers in China registered for Strip, Temperature, Forehead, Liquid Crystal
Record
| Listed by | Biosynergy, Inc., United States |
|---|---|
| FDA product code | KPD |
| Device type | Strip, Temperature, Forehead, Liquid Crystal |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2200 |
| Record published | 2016-09-01 |
| Record revised | 2022-05-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 5 |
| Distribution end date | 2022-02-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1000 | 1,000 | Withdrawn | |
| 1000 | 50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| FeverScan | LCR Hallcrest, LLC. | 28 |
| Crystaline II | LCR Hallcrest, LLC. | 9 |
| ThermoStrip | LCR Hallcrest, LLC. | 8 |
| Analog Crystaline ST | LCR Hallcrest, LLC. | 7 |
| DermaTherm | LCR Hallcrest, LLC. | 6 |
| TempAlert II | LCR Hallcrest, LLC. | 5 |
| ATI, Inc. | American Thermal Instruments, LLC | 5 |
| Crystaline® Moving Line | LCR Hallcrest, LLC. | 4 |
| FeverScan Ultra | LCR Hallcrest, LLC. | 4 |
| Redi-Temp® | Trademark Medical, L.L.C. | 3 |
| Spiras | LCR Hallcrest, LLC. | 3 |
| DeRoyal | Deroyal Industries, Inc. | 3 |
Showing 12 of 49. All products under Strip, Temperature, Forehead, Liquid Crystal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K841913 | 1984-11-02 |
| K833904 | 1983-12-27 |
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.