FDA.reportPublic FDA data

Launch

Primary DI
06947437960153
Brand
Launch
Company
SHENZHEN LAUNCH ELECTRICAL CO., LTD
Model
TAS03-15
Device description
Disposable skin temperature probe
Published
2019-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K181967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181967000Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd.2018-12-10FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947437960153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947437960153069474379601536947437960153

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, single-useA temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Regulatory Flags#

DUNS number
544922461
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947437902535Medtronic5944RL2025-02-08
06947437900265GE Healthcare2104724-0032021-05-28
06947437900272GE Healthcare2104724-0042021-05-28
06947437900289GE Healthcare2104751-0022021-05-28
06947437900296GE Healthcare2104750-0022021-05-28
06947437900302GE Healthcare2104752-0022021-05-28
06947437900319GE Healthcare2104724-0052021-05-28
06947437900326GE Healthcare2104724-0062021-05-28
06947437900333GE Healthcare2104724-0072021-05-28
06947437900340GE Healthcare58313982021-06-01
06947437900357GE Healthcare58313992021-06-01
06947437900364GE Healthcare58314002021-06-01
06947437900371GE Healthcare58314012021-06-01
06947437910431GE HealthcareMA01032020-04-27
06947437910448GE HealthcareME01032020-04-27
06947437910455GE HealthcareMA01052020-04-27
06947437910462GE HealthcareME01052020-04-27
06947437900067GE Healthcare2104722-0012018-01-22
06947437900074GE Healthcare2104723-0012018-01-22
06947437900081GE Healthcare2104724-0012018-01-22

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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
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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