FDA.reportPublic FDA data

Veridian

Primary DI
00845717004176
Brand
Veridian
Company
VERIDIAN HEALTHCARE LLC
Model
09-332
Catalog number
09-332
Device description
Premium Temple Touch Thermometer
Published
2016-09-24
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
K051422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051422000DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICEMedisim, Ltd.2005-09-01FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845717004173PackageGS136In Commercial Distribution
30845717004177PackageGS13In Commercial Distribution
00845717004176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084571700417310845717004173
3084571700417730845717004177
00845717004176008457170041768457170041760845717004176

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.

Contacts#

Phone, Email table
PhoneEmail
1-866-326-1313info@veridianhealthcare.com

Regulatory Flags#

DUNS number
830437997
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845717012171Trackstar302-WS3802026-05-28
00845717015509SmartHeart01-5502026-05-27
00845717012096Trackstar302-2110B2025-09-15
00845717013192SmartHeart UAM-710SH2025-12-12
10845717013199SmartHeart UAM-710SH2025-12-12
00682891216021Zewa216022024-06-21
00682891216014Zewa216012020-04-14
00845717010139Veridian Healthcare11-50Q12025-09-09
30845717010130Veridian Healthcare11-50Q12025-09-09
00845717011785R.P.M. PRO210-1114B2025-09-08
00845717011945R.P.M. PRO210-3110B2025-09-08
00845717012164Trackstar302-1110B2025-09-08
00845717011020Veridian Healthcare01-5742024-09-10
00845717011068R.P.M. PRO210-1113B2025-09-02
00845717011938R.P.M. PRO210-1113C2025-09-02
00845717012102Trackstar302-1113B2025-09-02
00845717012195Trackstar302-1114B2025-09-02
00682891216007Zewa216002019-07-02
00845717012287CoverGuard101-100T2025-08-15
00845717012294CoverGuard101-101T2025-08-15

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