FDA.reportPublic FDA data

Rexall

Primary DI
00845717090001
Brand
Rexall
Company
DOLGENCORP, LLC
Model
77-352
Catalog number
77-352
Device description
Rexall 60 Second Digital Thermometer
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K041516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041516000DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9Vega Technologies, Inc.2004-09-08FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845717090008PackageGS172In Commercial Distribution
30845717090002PackageGS16In Commercial Distribution
00845717090001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084571709000810845717090008
3084571709000230845717090002
00845717090001008457170900018457170900010845717090001

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-888-309-9030xx@xx.xx

Regulatory Flags#

DUNS number
068331990
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017276224771Rexall0172762247712020-09-07
00834533001414DG HealthBDGGC362026-03-23
00834533001445DG HealthBDGGS182026-03-23
10834533001411DG HealthBDGGC362026-03-23
10834533001442DG HealthBDGGS182026-03-23
00751774000030DG Health20002256N/A2026-02-20
10751774000037DG Health20002256N/A2026-02-20
00751774242461Rexall One Step Pregnancy Test2020-07-10
00751774250473Rexall One Step Pregnancy Test2020-07-10
00197344018737RexallDG4335DG43352025-10-02
00751774260472Dollar GeneralOne Step Pregnancy Test2025-05-09
00751774262469DG HealthOne Step Pregnancy TestN/A2025-05-09
00845717773591Rexall77-35977-3592016-09-24
10751774260479Dollar GeneralOne Step Pregnancy Test2025-05-09
10751774262466DG HealthOne Step Pregnancy TestN/A2025-05-09
00646011887409Rexall Sterile Saline Wound Wash88-50740-200-002024-10-04
00197344110059RexallDG4345DG43452024-08-08
10197344110056RexallDG4345DG43452024-08-08
00751774250787DG healthOne Step Pregnancy TestN/A2023-10-27
10751774250784DG healthOne Step Pregnancy TestN/A2023-10-27

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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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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