FDA.reportPublic FDA data

CVS Health

Primary DI
40504280825158
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
HTD8220
Device description
A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature from the inner ear. The device has an infrared probe and an LCD display. It is designed to take a temperature reading in approximately 2 seconds. This is a reuseable device.
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180387000Infrared Ear ThermometerHetaida Technology Co., Ltd.2019-01-10FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40504280825158PackageGS172In Commercial Distribution
00050428082515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4050428082515840504280825158
00050428082515000504280825150504280825150050428082515

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-271-0300info@180innovations.com

Regulatory Flags#

DUNS number
062312574
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10842942017015CVS Health6488802025-06-18
00050428135556CVS Health2703042026-10-31
00050428135563CVS Health7621462026-10-31
00050428135570CVS Health2100042026-10-31
00050428135587CVS Health9590382026-10-31
00050428286524CVS2845632026-10-26
00050428401064CVS9367982026-10-26
00050428401101CVS9368102026-10-26
00050428401125CVS9368252026-10-26
00050428401156CVS9369422026-10-26
00050428344095CVS Health4448302026-10-16
00050428034712CVS Health4820172026-10-10
00050428034743CVS Health7312312026-10-10
00050428142349CVS Health7312302026-10-10
00050428142677CVS Health3765472026-10-10
00050428143117CVS Health5516602026-10-10
00050428143124CVS Health5518142026-10-10
00050428339763CVS Health9356852026-10-10
00050428340523CVS Health4820192026-10-10
00050428340936CVS Health3758122026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970331862711TIXMORShenzhen Ruiankang Technology Co. Ltd.FLL2026-11-05
00681131280228EquateWAL-MART STORES, INC.FLL2026-11-03
09120095900816SteadyTempSteadySense GmbHFLL2026-11-03
09120095900823SteadyTempSteadySense GmbHFLL2026-11-03
00841709121746MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121777MidmarkMIDMARK CORPORATIONFLL2026-10-30
00860016681507UNIVERHEALTHHangzhou Universal Electronic Co.,Ltd.FLL2026-10-28
09120095900809SteadyTempSteadySense GmbHFLL2026-10-21
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
00885403523437HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
06970289030859foreverlittleHetaida Technology Co., LtdFLL2026-07-28
06953825911638ZKZOShenzhen Urion Technology Co., LtdFLL2026-07-23
B353UB25511UbiqVue MultiparameterLifesignals, Inc.FLL2026-07-20
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09