FDA.reportPublic FDA data

HealthSmart

Primary DI
00767056182257
Brand
HealthSmart
Company
D-M-S HOLDINGS, INC.
Model
18-225-000
Catalog number
18-225-000
Device description
STANDARD EAR THERMOMETER LENS COVERS
Published
2017-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K100488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100488000IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081Shenzhen Dongdixin Technology Co., Ltd.2010-07-22FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10767056182254PackageGS14In Commercial Distribution
30767056182258PackageGS16In Commercial Distribution
00767056182257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076705618225410767056182254
3076705618225830767056182258
00767056182257007670561822577670561822570767056182257

GMDN Terms#

Term, Definition table
TermDefinition
Electronic thermometer probe coverA device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.

Regulatory Flags#

DUNS number
062028220
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00767056160026MABIS01-160-02101-160-0212016-09-23
00767056160088MABIS01-160-08101-160-0812016-09-23
00767056160156MABIS01-160-15101-160-1512016-09-23
00767056160200MABIS01-160-20101-160-2012016-09-23
00767056160217MABIS01-160-21101-160-2112016-09-23
00767056160248MABIS01-160-24101-160-2412016-09-23
00767056410176MABIS09-141-01709-141-0172016-09-23
00767056110212MABIS01-110-02101-110-0212016-09-23
00767056234017MABIS05-234-01005-234-0102016-09-23
00767056300118MABIS01-130-01101-130-0112016-09-23
00767056300156MABIS01-130-01501-130-0152016-09-23
00767056300163MABIS01-130-01601-130-0162016-09-23
00767056322059MABIS05-223-06005-223-0602016-09-23
00767056400115MABIS01-140-01101-140-0112016-09-23
00767056400139MABIS01-140-01301-140-0132016-09-23
00767056400153MABIS01-140-01501-140-0152016-09-23
00767056400160MABIS01-140-01601-140-0162016-09-23
00767056400177MABIS01-140-01701-140-0172016-09-23
00767056550117MABIS01-155-01101-155-0112016-09-23
00767056600119MABIS05-260-01105-260-0112016-09-23

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
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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
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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