FDA.reportPublic FDA data

EVER+ONE

Primary DI
26947656112863
Brand
EVER+ONE
Company
Guangzhou Berrcom Medical Device Co., Ltd
Model
JXB-178
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical
SDVClinical Electronic Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2
SDVClinical Electronic ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130231000NON-CONTACT INFRARED THERMOMETERJinxinbao Electronic Co.,Ltd2013-10-15FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26947656112863PackageGS150In Commercial Distribution
06947656112869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2694765611286326947656112863
06947656112869069476561128696947656112869

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529391821
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947656111596RYCOMJXB-1832017-04-14
06947656114658BerrcomAOJ-70C2026-04-22
06947656117932BERRCOMJXB-1832026-01-21
06947656118014BerrcomJXB-1782026-01-21
06947656118021DedeksDT1192026-01-21
06947656118038DedeksDT1162026-01-21
06947656118045DedeksDT1132026-01-21
06947656118052BERRCOMET1022026-01-21
56947656117937BERRCOMJXB-1832026-01-21
36947656118015BerrcomJXB-1782026-01-21
66947656118023DedeksDT1192026-01-21
66947656118030DedeksDT1162026-01-21
66947656118047DedeksDT1132026-01-21
46947656118050BERRCOMET1022026-01-21
06947656112951OlangdaJXB-1782025-10-13
06947656112968OlangdaJXB-1822025-10-13
06947656114610BERRCOMNC0052025-10-13
06947656115143BERRCOMDT0052025-10-13
06947656115648BPET1082025-10-13
06947656115655BPET1082025-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00845717012188TrackstarVERIDIAN HEALTHCARE LLCSDV2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
00311917086569WalgreensWALGREEN CO.SDV2026-08-21
00311917086590WalgreensWALGREEN CO.SDV2026-08-21
00810110303812NuvomedNUVOMED, INC.SDV2026-08-19
00810110305014NuvomedNUVOMED, INC.SDV2026-08-19
06933257923157YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06933257952744YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06933257952751YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06942284618080JOYTECHJOYTECH HEALTHCARE CO.,LTDSDV2026-08-14
06970289030859foreverlittleHetaida Technology Co., LtdFLL2026-07-28
10197344219575MEDLINEMEDLINE INDUSTRIES, INC.SDV2026-07-24
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
06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758508865CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01