FDA.reportPublic FDA data

Rongfeng

Primary DI
06973074478195
Brand
Rongfeng
Company
SHEN ZHEN RONG FENG TECHNOLOGY CO.,LTD
Model
IR819
Device description
Infrared thermometer
Published
2023-10-17
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223037000Infrared Thermometer, Model: IR8807Shen Zhen Rong Feng Technology Co., Ltd.2023-07-21FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973074478195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973074478195069730744781956973074478195

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
548281437
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973074470045RongfengQT0012023-10-17
06973074470274RongfengQT001-012023-10-17
06973074470281RongfengQT0022023-10-17
06973074470298RongfengQT0032023-10-17
06973074470304RongfengQT0062023-10-17
06973074478072RongfengIR88072023-10-17
06973074478164RongfengIR8162023-10-17
06973074478188RongfengIR8182023-10-17
06973074479031RongfengIR9032023-10-17
06973074470311RongfengDT1022023-10-16
06973074470328RongfengDT1032023-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22