FDA.reportPublic FDA data

iProven

Primary DI
08719699630437
Brand
iProven
Company
Sevenground Trading B.V.
Model
NCT-336BLU
Device description
NCT-336BLU is a non-contact thermometer allows you to check your baby’s temperature without touching their forehead
Published
2019-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K171888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171888000Non-contact infrared body thermometerHetaida Technology Co., Ltd.2018-07-23FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719699630437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719699630437087196996304378719699630437

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

Contacts#

Phone, Email table
PhoneEmail
18555178225inventorym@masenainvest.com

Regulatory Flags#

DUNS number
492177197
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719481723408iProvènOXI-27 black2026-03-09
08719699630161iProvènOXI-27 black 2019-04-05
08719699636910iProvènBBT-3742025-09-17
08719699636958iProvènBBT-2162025-09-12
08719699636828iProvènBPM-352024-08-09
08719699636729iProvènDMT-77B2023-09-15
08719699636644iProvènBBB-112 Grey2023-06-30
08719699636651iProvènBBB-112 Blue2023-06-30
08719699630901iProvenFMH-139-52021-03-01
08719699633230iProvenFMH-139-52019-06-04
08719699633254iProvenFMH-139-32019-06-04
08719699636552iProvènDMT-77BT2022-11-28
08719699636538iProvènBBT-1272022-11-09
08719699636507iProvènBPM-6172022-07-14
08719699636477iProvènDMT-772022-06-24
08719699636491iProvènBPM-4172022-06-24
08719699634633iProvenFK-127-CO2021-03-19
08719699636217iProvenDMT-489 WHITE2020-12-11
08719699636248iProvenDMT-489 BLACK2020-12-11
08719699633315iProvenDMT-316B2020-07-21

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Primary DI, Brand, Company table
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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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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22