DermaTherm

Sharn temperature indicators read and display skin temperature. Use these indicators in your Pain Management Department to diagnose RSD, as well as to assess the effectiveness of nerve…

Registry build 21.09.26

Sharn temperature indicators read and display skin temperature. Use these indicators in your Pain Management Department to diagnose RSD, as well as to assess the effectiveness of nerve blocks within minutes by watching for a sympathetic rise in temperature. They are also useful when doing EMGs.

17manufacturers in China registered for this device type
6catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code KPD
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

Regulatory record for DermaTherm
Listed by LCR Hallcrest, LLC.
FDA product code KPD
Device type Strip, Temperature, Forehead, Liquid Crystal
Device class Class 2
Regulation 21 CFR 880.2200
Premarket notification Exempt
Record published 2016-09-23
Record revised 2020-02-24 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number
Storage Special storage condition: Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity; Storage environment temperature 60 to 104 °F; Storage environment humidity 15 to 95 % RH

Catalogue Numbers

Catalogue numbers for DermaTherm
Catalogue number Size Per pack Status
2150PB 250 In distribution
2100PB-SB 2 In distribution
2200PS 100 In distribution
2105PB 50 In distribution
2200PS-SB 2 In distribution
2100PB 100 In distribution

Same Product Code

Other products under the same FDA 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
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
CliniTrend LCR Hallcrest, LLC. 3

Showing 12 of 49. All products under Strip, Temperature, Forehead, Liquid Crystal

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer