FDA.reportPublic FDA data

BERRCOM

Primary DI
06947656112685
Brand
BERRCOM
Company
Guangzhou Berrcom Medical Device Co., Ltd
Model
JXB-182
Published
2020-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
16947656112682PackageGS140In Commercial Distribution
26947656112689PackageGS150In Commercial Distribution
46947656112683PackageGS124In Commercial Distribution
56947656112680PackageGS1100In Commercial Distribution
06947656112685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694765611268216947656112682
2694765611268926947656112689
4694765611268346947656112683
5694765611268056947656112680
06947656112685069476561126856947656112685

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic 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
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06947656112944COCOBEARJXB-1782025-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00860015688927HomedicsFKA DISTRIBUTING CO., LLCSDV2026-05-31
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27