What is FDA product code SDV?

A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. This product code is class II exempt, and was exempted, subject to the limitations of exemption, under the procedures established by section 510(m) of the FD&C Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 880.9 and the specific limitations of exemption as stated in the final order, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf

General Hospital › MonitoringClinical Electronic Thermometer

Predictive Temperature Module

Name: Predictive Temperature Module
Brand: Predictive Temperature Module

Temperature Parameter Module for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. The Temperature Module provides continuous body temperature readings at a variety of sites…

Registry build 21.09.26

Temperature Parameter Module for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. The Temperature Module provides continuous body temperature readings at a variety of sites including skin, rectal, nasal, esophageal, arterial, and venous.

49manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (24), Zhejiang (8), Jiangsu (6). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code SDV
Manufacturer	City	Province	Registered as	Device types
Avita (Wujiang) Co., Ltd.	Wujiang	Jiangsu	Contract manufacturer	15
Tianjin Choice Medical Device Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	12
Yahorng Dongguan Electronic Co Ltd	Guangdong	Guangdong	Contract manufacturer	8
Cotronic Technology Limited	Shenzhen, Guang Dong	Guangdong	Contract manufacturer	5
Dongguan Polygreen Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	4
Kunshan Radiant Innovation Co., Ltd.	Jiangsu	Jiangsu	Contract manufacturer	2
Boen Healthcare Co., Ltd.	Suzhou	Jiangsu	Specification developer	263
Shanghai Jolly Industrial Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	99
Shanghai Lions Industrial Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	82
Orantech Inc.	Shenzhen	Guangdong	Contract manufacturer	40
Xiamen Firstcare IMP. & EXP. Co., Ltd.	Xiamen	Fujian	Exporter	40
Beijing Choice Electronic Technololgy Co., Ltd.	Beijing	Beijing	Repacker / relabeller	30

Showing 12 of 49. All 49 manufacturers in China registered for Clinical Electronic Thermometer

Record

Regulatory record for Predictive Temperature Module
Listed by	Philips Medizin Systeme Böblingen GmbH, Germany
FDA product code	SDV
Device type	Clinical Electronic Thermometer
Device class	Class 2
Regulation	21 CFR 880.2910
Premarket notification	Exempt
Record published	2025-09-30

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	serial number
Storage	Storage environment humidity 15 to 95 % RH; Storage environment temperature -20 to 50 °C; Storage environment atmospheric pressure 57 to 107.5 KiloPascal

Catalogue Numbers

Catalogue numbers for Predictive Temperature Module
Catalogue number	Size	Status
Temperature Parameter Module		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Filac	Cardinal Health 200, LLC	16
iHealth	iHealth Labs, Inc.	11
Walgreens	Walgreen Co.	10
Yuwell® Infrared Ear Thermometer	Jiangsu Yuyue Medical Equipment & Supply Company Limited	8
Berrcom	Guangzhou Berrcom Medical Device Co., Ltd.	8
Genius	Cardinal Health 200, LLC	5
Ailifee	Alicn Medical Shenzhen, Inc	5
Fore Health	Fortechgrp Co., Ltd.	4
Easy@Home Digital Basal Thermometer	Easy Healthcare Corporation	4
Bblove	Alicn Medical Shenzhen, Inc	4
Up & Up	Target Health, Inc.	4
CVS	Woonsocket Prescription Center, Incorporated	4

Showing 12 of 50. All products under Clinical Electronic Thermometer

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.